2024 Report on Scientific Conferences With Expenses Over $30,000
Section 3074 of 21st Century Cures Act requires the FDA to report on scientific conferences hosted, sponsored, co-sponsored, or attendance at non-Federal Scientific Meetings with FDA expenses in excess of $30,000. The following outlines the total expenses for each scientific meeting together with other pertinent information including how the conference advanced the mission of the agency, a description of the conference activities. Section 3074 requires additional information of compelling circumstances for the costs exceeding $150,000.
2024 Annual Report
1. International Medical Device Regulators Forum
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Seattle, Washington
Conference Start Date: 09/16/2024
Conference End Date: 09/20/2024
Total FDA cost of the conference: $726,416.00
Total number of individuals whose expenses were paid by the FDA: 18
Explanation of how conference advanced the mission of FDA:
FDA’s mission is to protect and serve the public health. There is no greater impact for improving the public health in the medical device sector than by harmonizing globally on standards, laws, and policies. To harmonize is to reduce the costs and resources for every entity in the medical device ecosystem worldwide, which ultimately increases the quality of devices and expands market access. Toward the goal of global harmonization, IMDRF is the largest and most impactful collective of regulatory authorities, industry organizations, public health interest groups, and academics worldwide. The U.S., represented by CDRH, is a founding member of International Medical Device Regulators Forum.
General description of the scientific conference activities:
The United States is one of the founding and core members of the International Medical Device Regulators Forum (IMDRF). The Forum is a global collaboration between dozens of countries and hundreds of stakeholders to align on medical device standards, regulations, and policies. As a member of IMDRF, the U.S. (represented by FDA/CDRH) agreed to rotate the responsibility with other member nations of hosting the two in-person meetings and two virtual meetings held annually. On average, a member of IMDRF is required to host the two in-person meetings and two virtual meetings once every ten years. It is important to stress that IMDRF in-person sessions are meetings intended for worldwide stakeholders of IMDRF to discuss current work on harmonization of the Forum, to deliberate through a voting process on existing action items, and to propose next work items. Each meeting of the year builds on the work accomplished and priorities set from the prior meeting. The 26th session of IMDRF was structured similarly to prior years of in-person meetings – day one featured presentations and discussion between industry and regulators on the benefits of IMDRF globally; day two was an opportunity to stakeholders to express what they want to accomplish in IMDRF; day 3 was a smaller invite-only roundtable meeting where the head of CDRH / IMDRF Chair posed questions of regulators and leads voting on action items; day 4 was a closed meeting with the Management Committee and invited organizations to hear presentations by foreign regulators who seek membership into IMDRF, followed by voting on these applications by the Management Committee; and day 5 was a final closed meeting of the IMDRF Management Commitment to discuss the business of IMDRF and vote on all outstanding action items. In sum, the week of IMDRF meetings in September advanced the global harmonization, outreach, and membership work of IMDRF, which has grown since the March and June meetings in the United States. CDRH planned to have officials of high rank provide the opening remarks in September. FDA live tweeted the event on “X” and posted updates on its LinkedIn page.
Explanation/description of circumstances for conference exceeding $150,000:
The International Medical Device Regulators Form (IMDRF), which the United States co-founded, is a voluntary group of medical device regulators from around the world who agree that global harmonization of laws, policies, and standards is the best way to maximize resources and increase market access. IMDRF does not just aspire to harmonize through talk – the Forum has numerous working groups which drive the creation of best practice documents for the entire medical device ecosystem to use. These meetings are necessary for the member nations and other invited IMDRF stakeholders to discuss the ongoing work of the Forum (through working groups and other mechanisms), as well as vote on publication of documents and endorsement of working group projects. For the calendar year of 2024, the United States (represented by FDA/CDRH) was responsible for chairing the IMDRF, providing a Secretariat for the IMDRF, and hosting the two in-person and two virtual IMDRF meetings. As Secretariat of IMDRF in 2024, CDRH was responsible for creating all agendas, priorities, and invitations for the year. This year, CDRH’s priority as Chair was to increase the membership of IMDRF because more members equate greater resources for the Forum to do its work, and ultimately more medical devices available worldwide for the biggest number of people. At the March 2024 meeting of IMDRF, CDRH hosted the largest number of attendees in IMDRF history with 400 in person and 800 virtual. Similarly, over 550 private organizations in the medical device realm – including device companies, law firms, academia, and leading trade associations – attended in March, which reflects FDA’s belief that partnerships between public and private stakeholders are vital to ensure the health of medical product ecosystems. Since hosting the meeting in March, numerous embassies worldwide have reached out to FDA to request permission to attend the September meeting in order to collaborate on ways to increase market access to medical devices through IMDRF. This week-long session of IMDRF was a massive undertaking in terms of logistics, but vital to advancing the mission of CDRH and protecting the health of the medical device ecosystem worldwide.
2. Compounding Quality Center of Excellence Annual Conference
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Rockville, Maryland
Conference Start Date: 08/21/2024
Conference End Date: 08/23/2024
Total FDA cost of the conference: $665,600.00
Total number of individuals whose expenses were paid by the FDA: 20
Explanation of how conference advanced the mission of FDA:
The Compounding Quality Center of Excellence Annual Conference was a three-day year-end conference to enable engagement and information sharing between FDA and Outsourcing Facilities, in order to directly support FDA goals of ensuring the sector can provide products of reliable quality. CDER’s Office of Compliance, as well as other offices in CDER and other offices at the FDA, worked together to advance FDA’s public health mission related to drug compounding as well as effective implementation of federal law on drug compounding overall. The Drug Quality and Security Act of 2013 created “outsourcing facilities”, which is a new industry sector of drug compounders held to higher quality standards to protect patient health.
General description of the scientific conference activities:
This was a year-end conference for outsourcing facility staff to engage the sector on issues related to outsourcing facilities and drug production as well as educate the sector on relevant policy matters and FDA oversight approaches regarding outsourcing facilities and drug production. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other providers. This conference assisted the outsourcing facility industry meet its intended function through FDA engaging in several initiatives to address challenges and support advancement. These included the development and provision of practical and virtual training, as well as in-depth research to better understand barriers that impede growth and potential solutions.
Explanation/description of circumstances for conference exceeding $150,000:
The Center for Drug Evaluation and Research’s (CDER) mission is to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use, meet established quality standards and are available to patients. CDER’s Office of Compliance (OC) plays a critical role in protecting and promoting public health by shielding patients from poor quality, unsafe and ineffective drugs. The complexity of the human drug supply and development pipeline and the global nature of the regulated industry present unprecedented challenges to effective regulatory oversight. CDER’s Office of Compliance, as well as other offices in CDER (such as the Office of Pharmaceutical Quality) and other offices at the FDA (such as the Office of Regulatory Affairs), work together to advance FDA’s work related to drug compounding. Drug compounding is generally the practice of combining, mixing, or altering ingredients of a drug or active pharmaceutical ingredient (bulk drug substance) to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also present a risk to patients. Compounded drugs are not FDA-approved. Therefore, they do not undergo premarket review by FDA for safety, effectiveness, and quality. Since compounded drugs are subject to a lower regulatory standard than approved drugs, Federal law places conditions on compounding that are designed to protect the public health. The Drug Quality and Security Act of 2013 created “outsourcing facilities”, which is a new industry sector of drug compounders held to higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other providers. Seven years since its creation, this domestic industry is still relatively small (approximately 75 entities) and is experiencing growth and market challenges. FDA continues to find challenges concerning drug quality and safety during inspections. To help this industry meet its intended function, FDA formed the Compounding Quality Center of Excellence (COE) in 2019 to engage in a number of initiatives to address challenges and support advancement. One initiative includes holding an annual conference for the outsourcing facilities and associated stakeholders to learn and engage on emerging trends and compounding best practices.
3. International Medical Device Regulators Forum Conference
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Washington, District of Columbia
Conference Start Date: 03/11/2024
Conference End Date: 03/15/2024
Total FDA cost of the conference: $613,408.00
Total number of individuals whose expenses were paid by the FDA: 82
Explanation of how conference advanced the mission of FDA:
FDA’s mission is to protect and serve the public health. There is no greater impact for improving the public health in the medical device sector than by harmonizing globally on standards, laws, and policies. To harmonize is to reduce the costs and resources for every entity in the medical device ecosystem worldwide, which ultimately increases the quality of devices and expands market access. Toward the goal of global harmonization, IMDRF is the largest and most impactful collective of regulatory authorities, industry organizations, public health interest groups, and academics worldwide. The U.S., represented by CDRH, is a founding member of International Medical Device Regulators Forum.
General description of the scientific conference activities:
The International Medical Device Regulators Forum was one of CDRH’s Strategic Priorities, and CDRH has made the decision to support the work in this regulator's forum as the central point of medical device globalization and convergence efforts versus participating in multiple bilateral arrangements. The United States is one of the founding and core members of the International Medical Device Regulators Forum (IMDRF). The Forum is a global collaboration between dozens of countries and hundreds of stakeholders to align on medical device standards, regulations, and policies. As a member of IMDRF, the U.S. (represented by FDA/CDRH) agreed to rotate the responsibility with other member nations of hosting the two in-person meetings held annually. On average, a member of IMDRF is required to host the two in-person meetings once every ten years. It is important to stress that IMDRF in-person sessions are meetings intended for worldwide stakeholders of IMDRF to discuss current work on harmonization of the Forum, to deliberate through a voting process on existing action items, and to propose next work items. Attendees on days 1 and 2 were closely vetted, and attendance on days 3, 4, and 5 were by invite only to member nations of IMDRF and invited observers. The 25th session of IMDRF was structured as such – day one featured presentations and discussion between industry and regulators on the benefits of IMDRF globally; day two was an opportunity to stakeholders to express what they want to accomplish in IMDRF; day 3 was a smaller invite-only roundtable meeting where the head of CDRH / IMDRF Chair posed questions of regulators and leads voting on action items; day 4 was a closed meeting with the Management Committee and invited organizations to hear presentations by foreign regulators who seek membership into IMDRF, followed by voting on these applications by the Management Committee; and day 5 was a final closed meeting of the IMDRF Management Commitment to discuss the business of IMDRF and vote on all outstanding action items.
Explanation/description of circumstances for conference exceeding $150,000:
The International Medical Device Regulators Form (IMDRF), which the United States co-founded, is a voluntary group of medical device regulators from around the world who agree that global harmonization of laws, policies, and standards is the best way to maximize resources and increase market access. IMDRF does not just aspire to harmonize through talk, the Forum has numerous working groups, which drive the creation of best practice documents for the entire medical device ecosystem to use. Under the Standard Operating Procedures (SOPs) established and agreed to by all IMDRF members, including the United States, all member nations are required to meet two times per year in person and two times per year virtually to discuss the business of IMDRF. The member nations of the IMDRF Management Committee agreed to rotate annually the responsibilities of serving as Chair and Secretariat for the Forum, which include the responsibility to serve at the host nation for the two in-person IMDRF meetings. These meetings are necessary for the member nations and other invited IMDRF stakeholders to discuss the ongoing work of the Forum (through working groups and other mechanisms), as well as vote on publication of documents and endorsement of working group projects. For the calendar year of 2024, the United States (represented by FDA/CDRH) had the responsibilities of chairing the IMDRF, providing a Secretariat for the IMDRF, and hosting the IMDRF meetings. As Secretariat of IMDRF in 2024, CDRH was responsible for creating all agendas, priorities, and invitations for the year. This year, CDRH’s priority as Chair was to increase the membership of IMDRF because more members means greater resources for the Forum to do its work, and ultimately more medical devices available worldwide for the biggest number of people. As such, CDRH invited the largest number of countries in the history of IMDRF to attend this meeting (over 60). Upon hearing about the meeting in March, numerous embassies worldwide reached out to request permission to attend in order to collaborate on ways to increase market access to medical devices through IMDRF. Similarly, over 500 private organizations in the medical device realm – including device companies, law firms, academia, and leading trade associations – were invited to attend, which reflected FDA’s belief that partnerships between public and private stakeholders are vital to ensure the health of medical product ecosystems. In sum, the week of IMDRF meetings provided an opportunity for invited stakeholders to learn the current state of IMDRF work, pose challenges and questions to each other, and work together to discuss how best we can harmonize to improve public health globally. FDA live tweeted the event on “X” and posted updates on its LinkedIn page. This week-long session of IMDRF was a massive undertaking in terms of logistics, but vital to the health of the medical device community worldwide.
4. Society of Toxicology Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Salt Lake City, Utah
Conference Start Date: 03/10/2024
Conference End Date: 03/14/2024
Total FDA cost of the conference: $498,810.00
Total number of individuals whose expenses were paid by the FDA: 167
Explanation of how conference advanced the mission of FDA:
The Society of Toxicology (SOT) Annual conference brought together 5,000 plus toxicologists and those working in areas related to toxicology to share the latest science and technology in the field. The Society of Toxicology Annual Meeting is the leading toxicology conference that provides the most complete and in-depth coverage of toxicology with the goal of creating a safer and healthier world by advancing the science and impact of toxicology. The SOT Annual Meeting was the largest meeting of its kind. The SOT Annual Meeting also included the ToxExpo, which is the largest exhibition dedicated to toxicology and the biomedical sciences. ToxExpo featured 350 exhibitors, who lead the industry in developing cutting-edge products, services, and technology to benefit the toxicology community. Attending this conference promoted the field of toxicology or biotechnology research, supported the growth and development of the toxicology field, and shared the latest science and technology in the field, as well as made connections for possible future collaborations which is vital to the FDA mission. Attendance benefited the FDA by allowing scientist to develop ideas for future projects that will be beneficial to FDA. Sharing of up-to-date research and technology methods, with others to educate and protect the public health, allowed scientist to keep updated in the latest advanced assessments of toxicities associated with medical devices, new material, or combination devices to assist in reviews/memos/consults on devices that incorporate these materials or require performance testing involving toxicological analysis. Attendance also gave FDA the opportunity to interact with clinical and academic science professionals from across the nation to gain a national and international perspective into the latest advances of toxicology to stay on top of state-of-the-art concepts, tools, and techniques toxicology. This conference was beneficial for all FDA attendees and Non-Federal attendees associated with FDA.
General description of the scientific conference activities:
The Society of Toxicology annual meeting was the most important conference in the United States related to toxicological sciences. It covered the topics related to toxicological risk assessment (TRA) of medical devices, which it is very important to understand current trends related to long-term biocompatibility endpoint evaluation (subacute/sub-chronic/chronic systemic toxicity, genotoxicity, and carcinogenicity), leveraged by TRA, of orthopedic implants, as part of medical device safety evaluation in FDA. This annual event featured a broad range of scientific sessions and a thematic program that provides participants with a unique opportunity to deepen their knowledge in topical areas and interact with leaders in their respective disciplines. The scientific program includes Plenary Lectures and other featured sessions, Symposia, Workshops, Roundtable discussions, Informational Sessions, and a Regional Interest Session, as well as Platform and Poster Sessions.
Explanation/description of circumstances for conference exceeding $150,000:
The Society of Toxicology is committed to providing sound, balanced science information on toxicological topics of importance to human, environmental, and animal health. Over the years, toxicological research has helped identify risks and has informed rules, regulations, and tests to protect public health. It is the largest society representing scientists from industry, academia, and government in the field of toxicology, including many who work in the field of tobacco product toxicity. A high level of attendance at Society of Toxicology Annual Meeting was mission critical because attending this meeting will allow attendees to meet with industry and academia to discuss innovative technologies and to discuss the clinical data requirements for future device submissions. The scientific seminars are directly applicable to the attendee's job duties in the FDA and reach/disseminate FDA messages and materials to a diverse group of audiences (such as scientific academia, medical associations, state and local tobacco control, minority organizations, and public health groups). It was also mission critical as FDA is looking to fill several difficult-to-fill Toxicology positions within the Center. The attendees were able to hear different viewpoints and advance understanding. Attendees were also able to discuss the Center programs that can benefit IDE protocol design for devices that address unmet medical needs. This meeting aided in the professional development in the areas of toxicology, risk assessment, and biocompatibility that are used to assess safety concerns relevant to medical devices. Attendees attended workshops and symposia to open dialogue among scientific experts so that they can remain current with recent advances in the field and foster research collaborations. Attending the SOT annual meeting benefited the attendees as they were able to attend poster sessions, workshops, and symposia relevant to issues related to FDA's initiative to modernize toxicology and biocompatibility approaches. These interactions were relevant for attendees to stay current with the advances in medical device safety testing, and to provide expertise in biocompatibility consults for FDA.
5. International Association for Food Protection Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Long Beach, California
Conference Start Date: 07/14/2024
Conference End Date: 07/17/2024
Total FDA cost of the conference: $442,023.00
Total number of individuals whose expenses were paid by the FDA: 159
Explanation of how conference advanced the mission of FDA:
The International Association of Food Protection conference was critical to career development because there was a major emphasis on emerging food safety issues, the latest science, and innovative solutions to new and recurring problems. It also gave FDA attendees the opportunity to network with thousands of food safety professionals from around the globe. This meeting also allowed the opportunity to identify new cutting-edge laboratory technology that could potentially streamline my workflow in the lab and increase productivity to meet FDA’s core laboratory mission. The IAFP is a highly recognized, international scientific meeting hosting the top professionals in the food safety space. Attendance will better prepare FDA scientists to respond to stakeholder issues concerning new or novel technologies as well as emerging challenges and the potential threats to the food supply. The interaction with scientists, regulators, and policy makers from academia, industry, and federal/state regulatory partners was essential to effectively complete their regulatory food safety mission. Exclusions from such a conference significantly diminishes the agency’s ability to effectively respond to the latest food safety challenges.
General description of the scientific conference activities:
At the International Association of Food Protection conference, FDA interactively participated with global leaders sharing information on current and emerging food safety issues, the latest science, innovative solutions to new and recurring problems, and obtain the most late-breaking information on antimicrobial resistance in foodborne pathogens. This information was critical to FDA’s evaluation of antimicrobials and other alternative compounds for microbial food safety, ensuring that human and animal foods are properly evaluated for hazards to human and animal health. Some participants presented mission critical data to peers, and one chaired a professional development group (PDG) meeting and co-organize a symposium on pet food safety. Attendees learned up-to-date knowledge on detection, antimicrobial resistance, epidemiology, genomics, metagenomics, and public health. The IAFP Annual Meeting is attended by more than 3,500 of the top industry, academic and governmental food safety professionals from six continents. This renowned event owes its reputation and success to the quantity, quality, and diversity of each year’s program; the quality and relevance of exhibits sharing the latest in available technologies; leading experts speaking on a variety of timely topics; and special recognition of outstanding professionals and students for their contributions in the food safety field.
Explanation/description of circumstances for conference exceeding $150,000:
A high level of attendance at the International Association of Food Protection conference was required as it was focused entirely on food safety including innovative products, antimicrobial resistance mechanisms, and ensuring the safety of animal derived food products. It was one of the 2 largest and most well-respected conferences held annually and includes targeted interactions with industry, academics, and international regulatory participants. Attendance at this conference advanced the mission of the agency by exchanging scientific/regulatory information between FDA and its regulatory counterparts, international standard-setting organizations, and industry. The National Antimicrobial Resistance Monitoring System (NARMS) Antimicrobial Resistance (AMR) surface water work was shared with the international and national food safety community. Also, this conference provided in-depth discussions and analyses on a wide variety of timely topics by bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia. Attendees were able to hear FDA’s strategic priorities directly from the FDA Commissioner, Chief Counsel, Center Directors, and other key leaders within the Agency. Attendees also learned about the current Top Cases in Food Protection. The attendees were able to hear different viewpoints and advance understanding. This conference was beneficial for all FDA attendees.
6. International Council for Harmonization
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Prague, Czech Republic
Conference Start Date: 10/31/2023
Conference End Date: 11/01/2023
Total FDA cost of the conference: $251,690.00
Total number of individuals whose expenses were paid by the FDA: 49
Explanation of how conference advanced the mission of FDA:
The International Council for Harmonization conference was directly related to the mission and work of FDA in assisting with the application of technical guidelines and requirements for tobacco product registration and the maintenance of such registrations as they contribute to the protection of public health. Attendance of this event provided FDA attendees the information they need to apply within their regulatory research within FDA to benefit the technical guidelines and requirements pertaining to blood safety.
General description of the scientific conference activities:
The International Council for Harmonization Biannual Meeting in Prague, Czech Republic, enabled in-person meetings for a limited number of expert working groups identified by the ICH Management Committee as most critically in need of in-person discussion to resolve novel or complex technical issues and continue to make progress toward completion of their guideline. This meeting regarded the development of a guidance document used in review of pharmacology and toxicology review of products regulated by FDA. The development of the International Counsel for Harmonization (ICH) guidance involves multiple regulatory agencies from different countries and industry representatives.
Explanation/description of circumstances for conference exceeding $150,000:
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner, which aligns with the FDA mission. Harmonization is achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. The International Council for Harmonisation bi-annual meeting provided the opportunity to bring together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.
7. Small Business Regulatory Education for Industry Annual Conference
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: College Park, Maryland
Conference Start Date: 05/29/2024
Conference End Date: 05/30/2024
Total FDA cost of the conference: $248,689.00
Total number of individuals whose expenses were paid by the FDA: 29
Explanation of how conference advanced the mission of FDA:
This Small Business Regulatory Education for Industry Annual Conference enabled its members and business partners to collaborate, exchange ideas, develop professionally, and advocate the effective use of information management to create awareness of FDA’s regulatory requirements and current activities throughout the communities they serve. Historically, the conference has also been viewed as a tool to improve the quality of regulatory submissions.
General description of the scientific conference activities:
The REdI conference is an annual event in which three FDA medical product Centers (CBER, CDER, CDRH) participate jointly. The purpose of this conference was to provide small businesses in the pharma/device/biotech/vaccine fields with knowledge on different regulatory topics/issues of the day (e.g., areas of widest knowledge gaps). OBRR was invited to speak at the 2024 conference and provided a talk on OBRR’s approach to blood establishment licensure. This gave attendees an overview of what FDA reviews in blood licensure applications to ensure the availability and safety of the blood supply.
Explanation/description of circumstances for conference exceeding $150,000:
A high level of attendance at the Small Business Regulatory Education for Industry Annual Conference was mission critical because attendees learned directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course was designed to provide participants with a strong foundation in the FDA’s regulatory requirements and also create awareness of current activities. Innovation of medical products, whether it be drugs, devices, or biologics, is a continual journey that advances the needs of patients today and of future generations. Innovation takes form in many spaces such as research, product design, data collection and analysis, and we’re currently bearing witness to a golden age of technology involving artificial intelligence and genomics. This session provided a perspective of the current state at the FDA, both with current activities and what’s to come. This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. This forum also allowed FDA to share targeted regulatory information to attendees. This in turn assisted sponsors submitting more complete application to the FDA, which should ultimately reduce the review time. This meeting was also of invaluable assistance to both CDER and SBIA staff, as it will serve as reference and training material to help direct them in producing relevant material responsive to their audience's inquiries and needs.
8. United States Public Health Service Symposium
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Jacksonville, Florida
Conference Start Date: 06/24/2024
Conference End Date: 06/27/2024
Total FDA cost of the conference: $243,555.00
Total number of individuals whose expenses were paid by the FDA: 132
Explanation of how conference advanced the mission of FDA:
Attendance at the United States Public Health Service Symposium was mission critical to FDA since FDA ensures that USPHS officers are trained and ready to address national public health crisis. The U.S. Public Health Service Scientific and Training Symposium was the preeminent event offering an incomparable range of continuing education seminars on the latest trends and innovations in public health care delivery, administration, and research. It also provided targeted training courses covering disaster preparedness, readiness response and other areas critical to maintaining our nation's security and public health infrastructure. Dedicated professionals work in diverse but complementary fields such as disease control and prevention; emergency response; health research; environmental health; health education; regulation of food, drugs, and medical devices; mental health and substance abuse; health care delivery; and global health security, and all have the common goal of optimizing the health of our nation and the world.
General description of the scientific conference activities:
The U.S. Public Health Service (USPHS) Scientific and Training Symposium served as the premiere meeting for all USPHS Commissioned Officers. This event was the only annual meeting dedicated exclusively to the work of the USPHS Commissioned Corps officers, where officers and USPHS leadership come together to discuss solutions to the Nation's pressing public health issues. PHS Officers’ attendance strengthened the nation’s public health and emergency response capability, while building relationships that will further the mission and objectives of their respective agencies and provide them specific education and training based on their specialties. A key aspect of the mission of the U.S. Public Health Service is advancing the health and safety of our nation.
Explanation/description of circumstances for conference exceeding $150,000:
The United States Public Health Service Commissioned Corps, also referred to as the Commissioned Corps of the United States Public Health Service, is the federal uniformed service of the U.S. Public Health Service and one of the eight uniformed services of the United States. They work on the front lines of public health. Their medical, health, and engineering professionals fight disease, conduct research, and care for patients in underserved communities across the nation and throughout the world. They serve in agencies across the government as physicians, nurses, dentists, veterinarians, scientists, engineers, and other professionals. The United States Public Health Service Commissioned Officers Foundation for the Advancement of Public Health hosted the Symposium. This conference represented the one recurring event dedicated entirely to the public health, workforce, mission readiness and career development issues of Commissioned Corp officers. In order to maintain licensure and professional competency, officers must take continuing education coursework each year. This enables them to keep current with state-of-the-art practices and technology and to remain proficient in the various agency programs to which they are assigned. Each year the Commissioned Officers complete their continuing education requirements in a variety of venues. The U.S. Public Health Service Education and Training Symposium was an excellent means of obtaining continuing education credits across a variety of disciplines. Attendance enabled FDA Commissioned Corps officers to take the required course work to keep them to keep current with current practices and technology and to remain proficient in the various agency programs to which they are assigned. Attending this conference was mission critical as it supports FDA’s mission with emphasis on promoting public health. Reviewers must have updated knowledge and training to enable management to make fully informed approval and disapproval decisions regarding medical device applications. This training was an unique opportunity for professional development and networking since the conference is the only annual, in-person conference for PHS Commissioned Corps officers.
9. Drug Information Association Global Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 06/16/2024
Conference End Date: 06/20/2024
Total FDA cost of the conference: $230,166.00
Total number of individuals whose expenses were paid by the FDA: 72
Explanation of how conference advanced the mission of FDA:
The Drug Information Association (DIA) Global Annual conference had a positive impact on FDA’s initiatives to modernize our regulatory submission and document management processes and technologies by providing leading edge information regarding the electronic regulatory submission industry by demonstrating novel ways to manage and present submission materials to FDA regulators. The DIA 2024 conference was the essential compass for igniting healthcare product development and charting new courses of knowledge. The meeting charted new horizons in healthcare, propelled by visionary strategies and impactful collaborations among patients, regulators, researchers, and esteemed industry professionals. This global multidisciplinary assembly converged, illuminated diverse perspectives, and harnessed collective experiences, with a shared goal of tackling the most critical challenges. The DIA Annual Meeting provided the best opportunity for individuals involved in regulatory and scientific drug discovery activities with an opportunity to learn about the latest developments needed to carry on their scientific responsibilities. Further, DIA allowed an outlet for FDA scientists to interact with their peers from around the world, exchange information and ideas, and network in an effort to build new relationships.
General description of the scientific conference activities:
The Drug Information Association 2024 Global Annual Meeting invited industry, regulators, governments, academics, innovators, and patients to network, problem-solve, and discuss global and local challenges facing the life sciences community. FDA activities are designed to broaden professional skills and to enrich relations in the pharmaceutical and biotech industry, providing the Agencies perspective on the regulation of pharmaceuticals through inspection of manufacturing pharmaceutical establishments. The DIA annual meeting was a widely attended meeting by professionals in the pharmaceutical and medical device industry, and it is the foremost regulatory scientific professional organization in the country. Their entire focus was issues that bring together regulators, industry, academia and now patients in a neutral forum. DIA is the largest global interdisciplinary event that brought together 7,000+ key thought leaders and innovators from industry, academia, regulatory and government agencies, health, patient, and philanthropic organizations from around the globe and across all disciplines involved in the discovery, development, and life cycle management of health care products.
Explanation/description of circumstances for conference exceeding $150,000:
The Drug Information Association (DIA) Global Annual conference required a high level of attendance at this meeting to explore a neutral and transparent global forum and exchange ideas to further scientific and medical innovations. This meeting offered education and training in the field of cell and gene therapies drug laws. This annual Conference addressed complex legal, regulatory, compliance, and policy issues in all facets of the FDA-regulated industry. It provided in-depth discussions and analyses on a wide variety of timely topics by bringing together experts from the federal government, industry, non-profit, patient and consumer advocates, consulting organizations, and academia. Attending this meeting allowed one to gain knowledge on multidisciplinary regulatory products to further scientific and medical innovations on igniting healthcare product development and charting new courses of knowledge in the field of cell and gene therapies. The attendees also gained knowledge and stay up to date with pressing topics in the life sciences field, propose innovative ways to combat daily obstacles within the field of gen and cell therapies. This supported our research and review of files within FDA. This was critical to engage stakeholders for regulatory and research activities and exchange the latest information and disseminate FDA regulations as it pertains to the field of cell and gene therapy and participate on the panel discussion, which was in support of the FDA mission in protecting human health. High attendance to the DIA Global Annual Meeting provided the best opportunity for individuals involved in regulatory and scientific drug discovery activities with an opportunity to learn about the latest developments needed to carry on their scientific responsibilities. Further, DIA allowed an outlet for FDA scientist to interact with their peers from around the world, exchange information and ideas and network to build new relationships. DIA is a widely attended meeting by professionals in the pharmaceutical and medical device industry, and it is the foremost regulatory scientific professional organization in the country.
10. International Council on Harmonisation Spring Biannual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Fukuoka, Japan
Conference Start Date: 06/01/2024
Conference End Date: 06/05/2024
Total FDA cost of the conference: $199,216.00
Total number of individuals whose expenses were paid by the FDA: 43
Explanation of how conference advanced the mission of FDA:
This mission of the International Council on Harmonisation Spring Biannual Meeting was to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines developed and registered in the most resource-efficient manner. The International Council for Harmonisation bi-annual meeting provided the opportunity to bring together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. This meeting advanced regulatory harmonization of technical standards and regulatory reliance and convergence of standards and processes. International harmonization of essential technical guidelines enables more efficient drug development, and regulatory reliance and resilience during global public health emergencies. ICH’s mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner, which aligns with the FDA mission. FDA is a founding member of the ICH and has experts designated in several of the ICH Expert Working Groups. FDA’s attendance was essential for the work groups to progress in harmonization of various guidance documents.
General description of the scientific conference activities:
This International Council on Harmonisation Spring Biannual Meeting regarded the development of a guidance document used in review of pharmacology and toxicology review of products regulated by FDA. The development of the International Counsel for Harmonization (ICH) guidance involved multiple regulatory agencies from different countries and industry representatives. The ICH Assembly meets on a biannual basis in conjunction with meetings of the ICH Management Committee, ICH MedDRA Management Committee and ICH technical Working Groups. The expert groups of FDA address a range of critical topics including drug safety, efficacy, quality and electronic standards discussed in the ICH conference.
Explanation/description of circumstances for conference exceeding $150,000:
A high level of attendance at the 2024 International Council on Harmonisation Spring Biannual Meeting in Fukuoka, Japan provided the FDA perspective for international harmonization of essential technical guidelines, which enabled more efficient drug development and regulatory reliance and resilience during global public health emergencies. Attendees served on a panel and elicit/exchange information on FDA regulations as it pertains to the field of cell and gene therapy drug development in support of the Agency's mission to protect health and science. This conference was critical to engage stakeholders for regulatory and research activities and exchange the latest information as well as disseminate FDA regulations as it pertains to this topic. Also, the conference offered education and training on the Technical Requirements for Pharmaceuticals for Human Use (ICH) Meeting to advance regulatory harmonization of technical standards and regulatory reliance and convergence of standards and processes. The ICH Assembly meets on a biannual basis in conjunction with meetings of the ICH Management Committee, ICH MedDRA Management Committee, and ICH technical Working Groups. The ICH Biannual meeting in Fukuoka allowed an in-person meeting for a limited number of expert working groups identified by the ICH Management Committee as most critically in need of in-person discussion to resolve novel or complex technical issues and continue to make progress toward completion of their guideline. These expert groups addressed a range of critical topics including drug safety, efficacy, quality, and electronic standards.
11. Good Clinical Practice and Pharmacovigilance Symposium
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: College Park, Maryland
Conference Start Date: 02/13/2024
Conference End Date: 02/15/2024
Total FDA cost of the conference: $184,679.00
Total number of individuals whose expenses were paid by the FDA: 23
Explanation of how conference advanced the mission of FDA:
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. SBIA outreach activities include hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic drug, device and biotechnology industries. Attendance at this forum was critical in allowing quality assurance essential to human, animal, and environmental health worldwide.
General description of the scientific conference activities:
This Good Clinical Practice and Pharmacovigilance Symposium conference focused on Global Clinical Trials in Good Clinical Practice, Bioequivalence, and Pharmacovigilance in the post pandemic world. Presentations and panel discussions provided information on the recent updates made to ICH E6(r3) and regulatory perspectives on implementation of proportionate and risk-based approaches to the design and conduct of the trial to help ensure that the quality of the trial data generated is of sufficient quality to support good decision making. Panelists discussed continuing developments in novel operational approaches, data sources, and technologies used in clinicals trials, as well as novel approaches to regulatory inspections.
Explanation/description of circumstances for conference exceeding $150,000:
The Good Clinical Practice and Pharmacovigilance Symposium was a major program element for the FDA/CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from and regulators and small business owners, about their questions/concerns about the FDA regulatory procedures. This forum allowed FDA to share targeted regulatory information to attendees. This in turn assisted in sponsors submitting more complete application to the FDA, which should ultimately reduce the review time. CDER SBIA helps empower small businesses in their interactions with FDA and aids those businesses in the development of more complete submissions and first-cycle drug approvals. SBIA events target small pharmaceutical/devices/biologics business but in fact are widely attended by all levels of industry including small, medium, and large pharma with attendees exhibiting varied levels of expertise. This Good Clinical Practice and Pharmacovigilance Symposium conference focused on Global Clinical Trials in Good Clinical Practice, Bioequivalence, and Pharmacovigilance in the post pandemic world. Attendance at this forum was critical in allowing quality assurance essential to human, animal, and environmental health worldwide.
12. Society For Research on Nicotine And Tobacco Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Edinburgh, Scotland
Conference Start Date: 03/20/2024
Conference End Date: 03/23/2024
Total FDA cost of the conference: $183,127.00
Total number of individuals whose expenses were paid by the FDA: 28
Explanation of how conference advanced the mission of FDA:
Tobacco control researchers and practitioners from all over the globe attend the Society For Research on Nicotine And Tobacco Annual Meeting to present their work. FDA not participating in the SRNT conference would have disrupted our ability to maintain the most current research, discussions, and questions circulating the tobacco control space. Having FDA presence at the SRNT conference allowed FDA to be informed on the intersection of tobacco products, cessation and prevention messaging, and regulatory science. The SRNT also afforded FDA an opportunity to raise awareness of the Agency's work and engage with others in the field with shared interests and priorities.
General description of the scientific conference activities:
The Society For Research on Nicotine And Tobacco Annual Meeting was the principal forum for the latest developments in the research and practice in the field of nicotine and tobacco research and was therefore a major annual opportunity for professional development for economists working on tobacco-related policy. The plenary address, paper sessions, plenary addresses, symposia and scientific poster sessions covered all aspects of the tobacco and nicotine research including, policy, regulatory science, health, and epidemiology and were therefore relevant for the professional development and understanding of the available scientific evidence and its applicability to priority tobacco regulations and policies.
Explanation/description of circumstances for conference exceeding $150,000:
The Society For Research on Nicotine And Tobacco Annual conference was for professional development. The plenary address, paper sessions, plenary addresses, symposia and scientific poster sessions covered all aspects of the tobacco and nicotine research including, policy, regulatory science, health, and epidemiology and were therefore relevant for the professional development and understanding of the available scientific evidence and its applicability to priority tobacco regulations and policies. The SRNT is a professional association dedicated exclusively to the support of researchers, academics, treatment professionals, and government employees. The society works across disciplines in the field of nicotine and tobacco research. This international organization has members in more than 40 countries. In the U.S., the SRNT works with FDA as well as NCI and NIDA to advance tobacco research and provide FDA with scientific support for regulatory actions. The SRNT conference was also a space for tobacco control and health professionals to gain new knowledge concerning nicotine from the molecular to societal level. This conference brought together researchers from global and domestic level of health organizations and firms from various academic, governmental, and institutional organizations.
13. Food and Drug Law Institute Annual Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, District of Columbia
Conference Start Date: 05/15/2024
Conference End Date: 05/16/2024
Total FDA cost of the conference: $178,794.00
Total number of individuals whose expenses were paid by the FDA: 240
Explanation of how conference advanced the mission of FDA:
Attending the 2024 Food and Drug Law Institute Annual Conference (FDLI) conference was beneficial to advance staff understanding, continue the dialog with stakeholders on advancements, safeguards, and regulation as well as to engage with stakeholders on regulatory science programs, which all supports the FDA mission. This conference provides a unique opportunity to delve into the complex legal, regulatory, compliance, and policy issues currently impacting the FDA-regulated industry. The conference brings together experts from federal government, industry, the private bar, non-profit organizations, patient and consumer advocacy groups, consulting organizations, and the world of academia. This was an important opportunity to network with key stakeholders both within government and outside, many of whom are either in direct or indirect contact with FDA through daily job duties. It is also vital to stay up to date on current issues, challenges, and current thinking.
General description of the scientific conference activities:
The 2024 Food and Drug Law Institute Annual Conference (FDLI) conference provided a unique opportunity to delve into the complex legal, regulatory, compliance, and policy issues currently impacting the FDA-regulated industry. The conference brought together experts from federal government, industry, the private bar, non-profit organizations, patient and consumer advocacy groups, consulting organizations, and the world of academia. This year’s conference was more than just an exchange of ideas, but it was a celebration of FDLI’s rich history and accomplishments. The FDLI examined the most timely and significant topics in FDA’s field as well as what’s on the horizon. The FDLI was an important conference to attend based on the scope of topics encountered every day in the FDA, where FDA focuses on the high-level impact of current challenges in the healthcare space.
Explanation/description of circumstances for conference exceeding $150,000:
The 2024 Food and Drug Law Institute Annual Conference (FDLI) was the premier conference for the food and drug law community. The annual conference addressed complex legal, regulatory, compliance, and policy issues in all facets of the FDA-regulated industry. There were in-depth discussions and analyses on a wide variety of topics by bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia. Attendees at this year's conference heard FDA's strategic priorities directly from the FDA Commissioner, Chief Counsel, Center Directors, and other key leaders within the Agency; they gained in-depth knowledge of each FDA Center by attending consecutive Center Director sessions; and they joined high-level colleagues in food and drug law to hear different viewpoints, shape policy, and advance understanding. In-person attendance was mission critical because the conference offered education and training in the field of food and drug law. FDLI’s scope covered all industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities in the U.S. and globally, including drugs, medical devices, food, dietary supplements, cosmetics, veterinary, and tobacco products. This year’s conference examined the most timely and significant topics in our field as well as what’s on the horizon. Attendees also learned about the current Top Cases in Food and Drug Law. This provided the professional development to maintain knowledge of legal issues impacting FDA. The discussions presented at this conference on hotly debated areas of medical device law were particularly relevant to FDA. The attendees were able to hear different viewpoints and advance understanding. Attendance also kept FDA staff updated on an array of policy and legal issues across numerous GAO/OIG audits. This conference was beneficial for all FDA attendees.
14. Small Business Regulatory Education for Industry Advancing Generic Drug Development
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Bethesda, Maryland
Conference Start Date: 09/24/2024
Conference End Date: 09/25/2024
Total FDA cost of the conference: $160,841.00
Total number of individuals whose expenses were paid by the FDA: 50
Explanation of how conference advanced the mission of FDA:
This forum (the Small Business Regulatory Education for Industry Advancing Generic Drug Development conference) allowed FDA to share targeted regulatory information to attendees. This in turn assisted in sponsors submitting more complete application to the FDA, which should ultimately reduce the review time. This meeting was also of invaluable assistance to both FDA/CDER and SBIA staff, as it served as reference and training material to help direct them in producing relevant material responsive to their audience's inquiries and needs.
General description of the scientific conference activities:
The purpose of this science-focused workshop (the Small Business Regulatory Education for Industry Advancing Generic Drug Development conference) was to communicate to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development. FDA linked GDUFA science and research on complex drug products to product-specific guidance development, discussed pre-ANDA meetings and review, and examined various areas of complex product science.
Explanation/description of circumstances for conference exceeding $150,000:
The Small Business Regulatory Education for Industry Advancing Generic Drug Development was of great importance because this was a conference where FDA experts demonstrated the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Attendees dissected complex scientific challenges in ANDAs alongside FDA experts; gained insights into GDUFA III progress as well as GDUFA science, researched on complex products and scientific issues to product-specific guidance development; and attended pre-ANDA and ANDA meeting discussions. The workshop also highlighted innovative science and cutting-edge methodologies in generic drug development both within the U.S. and globally. In-person attendees enjoyed interactive poster sessions with FDA scientists, featuring topics like guidance development, advanced analytics, and PBPK modeling; lively discussions and Q&A with FDA experts; and virtual attendees had access to all presentations and panel discussions, minus the poster session.
15. Small Business Regulatory Education for Industry Generic Drugs Forums
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Bethesda, Maryland
Conference Start Date: 04/10/2024
Conference End Date: 04/11/2024
Total FDA cost of the conference: $160,841.00
Total number of individuals whose expenses were paid by the FDA: 27
Explanation of how conference advanced the mission of FDA:
The Small Business Regulatory Education for Industry Generic Drugs Forums was an annual, two-day event that offered attendees the opportunity to hear from FDA subject matter experts from every part of the pre-ANDA program and ANDA assessment program. The purpose of the meeting was to educate the small business generic pharmaceutical industry on key elements associated with the generic drug development continuum. This meeting was a major program element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. SBIA outreach activities include hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic drug, device, and biotechnology industries. CDER SBIA helps empower small businesses in their interactions with FDA and aids those businesses in the development of more complete submissions and first-cycle drug approvals. SBIA events target small pharmaceutical/devices/biologics business but in fact are widely attended by all levels of industry including small, medium, and large pharma with attendees exhibiting varied levels of expertise.
General description of the scientific conference activities:
The purpose of the Small Business Regulatory Education for Industry Generic Drugs Forums was to educate the small business generic pharmaceutical industry on key elements associated with the generic drug development continuum. This meeting was a major program element for the FDA/CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. This forum allowed FDA to share targeted regulatory information to attendees. This in turn assisted in sponsors submitting more complete application to the FDA which should ultimately reduce the review time.
Explanation/description of circumstances for conference exceeding $150,000:
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. SBIA outreach activities include hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic drug, device, and biotechnology industries. CDER SBIA helps empower small businesses in their interactions with FDA and aids those businesses in the development of more complete submissions and first-cycle drug approvals. SBIA events target small pharmaceutical/devices/biologics business but in fact are widely attended by all levels of industry including small, medium, and large pharma with attendees exhibiting varied levels of expertise. The Generic Drugs Forum was an annual, two-day event that offered attendees the opportunity to hear from FDA subject matter experts from every part of the pre-ANDA program and ANDA assessment program. The purpose of the meeting was to educate the small business generic pharmaceutical industry on key elements associated with the generic drug development continuum. This meeting was a major program element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. CDER's Office of Generic Drugs (OGD) was closely worked with in producing this forum, which allowed FDA to share targeted regulatory information to attendees. This in turn assisted in sponsors submitting more complete application to the FDA which should ultimately reduce the review time. The goal of the forum was to provide practical regulatory information to aid prospective applicants in submitting complete and high-quality applications to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines. This year’s theme was Regulatory Considerations to Enhance Generic Drug Access, and the agenda addressed essential regulatory information on how to engage with the Agency and gain information about ANDA development and ANDA assessment. Presentations focused on resources, best practices, common deficiencies, and opportunities to engage with the Agency from pre-ANDA to post-approval submissions.
16. American Academy of Orthopaedic Surgeons Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Francisco, California
Conference Start Date: 02/12/2024
Conference End Date: 02/16/2024
Total FDA cost of the conference: $158,010.00
Total number of individuals whose expenses were paid by the FDA: 38
Explanation of how conference advanced the mission of FDA:
Participation in the American Academy of Orthopaedic Surgeons Annual Meeting allowed FDA employees to gain insights into the latest advancements in orthopaedic medical devices, prepare for anticipated submissions, and identify potential issues related to marketing violations, such as improper labeling or promotional materials. Recognized as the premier CME event for Orthopaedic Surgery, the AAOS meeting fulfilled the continuing education requirements necessary for board-certified and licensed medical professionals, supporting the FDA’s mission.
General description of the scientific conference activities:
The American Academy of Orthopaedic Surgeons conference offered FDA employees the chance to acquire firsthand knowledge about emerging and current trends in device-related treatments for the spinal column and associated neurological structures. Attendees also had the opportunity to observe sponsors' marketing strategies for regulated orthopaedic devices in person. The specialty day session featured subspecialty training tailored to orthopaedics, such as Hip and Knee Arthroplasty CME, presented by the American Association of Hip and Knee Surgeons (AAHKS).
Explanation/description of circumstances for conference exceeding $150,000:
A high level of attendance at American Academy of Orthopedic Surgeons (AAOS) Annual Meeting was mission critical because the conference was the annual scientific meeting and benefited FDA employees for knowing the most updated innovations for orthopedic medical devices, preparing for the possible incoming submissions, and discovering possible marketing violation issues (e.g., inappropriate labeling/ marketing materials). The AAOS meeting was the leading meeting for the specialty of Orthopedic Surgery. It provided required CME for maintenance of board certified, licensed medical professionals for the FDA mission. This meeting provided the employees an opportunity to gain firsthand knowledge on emerging and current trends for treatments regarding device related treatment of the spinal column and its related neurological structures. There was also an in-person view of sponsor's marketing efforts of regulated orthopedic devices.
17. American Association of Pharmaceutical Scientists PharmSci 360
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Orlando, Florida
Conference Start Date: 10/22/2023
Conference End Date: 10/25/2023
Total FDA cost of the conference: $154,006.00
Total number of individuals whose expenses were paid by the FDA: 55
Explanation of how conference advanced the mission of FDA:
The American Association of Pharmaceutical Scientists PharmSci 360 Conference was the world's premier gathering of pharmaceutical scientists. The attendees gained knowledge of cutting-edge research by academia and industry. Since veterinary medicine is a poorly represented component of the pharmaceutical sciences, it was essential that FDA/CVM be present as well as other Centers, so that it could both incorporate this information into the work done at CVM as well as to ensure that CVM’s concerns and challenges were adequately addressed within the context of this evolving scientific area. FDA attendance overall at this conference allowed for attendee exposure to the latest scientific trends and reviewing hundreds of scientific posters while attending sessions featuring presentations by leading researchers.
General description of the scientific conference activities:
The American Association of Pharmaceutical Scientists PharmSci 360 Conference combined all the energy of a large scientific conference with the intimacy of a small niche meeting. It featured six tracks, five of which were split equally between chemical and biomolecule drug programming. These tracks encompassed many areas making the biggest headlines today. Attending this meeting allowed FDA attendees to stay on top of the latest scientific trends by attending sessions featuring presentations by leading researchers and experts. They also were able to review hundreds of scientific posters and see new research that can help them advance their work, and they were also able to participate in partner presentations focused on practical science and best practices that can improve the efficiency of FDA. The state-of-the-art technologies in manufacturing, modeling, and pharmacokinetic research was showcased, discussed, and debated at this meeting as well as there were workshops covering all aspects of the pharmaceutical science. Networking with experts in this field provided new opportunities for growing insights and solutions for current regulatory challenges.
Explanation/description of circumstances for conference exceeding $150,000:
A high level of attendance at The American Association of Pharmaceutical Scientists PharmSci 360 was mission critical because the conference offered access to cutting-edge research to be applied to current science. Staying on top of the latest scientific trends by attending sessions featuring presentations by leading researchers and experts is critical for the FDA. Attendees had the opportunity to review hundreds of scientific posters, see new research that can help advance their work, and participate in Partner Presentations focused on practical science and best practices that can improve the efficiency of the FDA. Participation was also an opportunity to develop and attain knowledge in advanced manufacturing techniques used in continuous manufacturing, while looking to broaden Inter collaboration, and improve networking. Career development opportunities were also available to help attendees improve critical thinking skills, advance leadership skills, promoting inclusion, and work-life balance. This conference benefited all FDA attendees, improving their efficiency and effectiveness.
18. American Association for Cancer Research Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 04/05/2024
Conference End Date: 04/10/2024
Total FDA cost of the conference: $134,449.00
Total number of individuals whose expenses were paid by the FDA: 37
Explanation of how conference advanced the mission of FDA:
The “Biomarkers” research category at the American Association for Cancer Research (AACR) Annual Meeting featured presentations, including some that showcased a novel error-corrected next-generation sequencing assay (CarSeq) developed in the lab and its potential application in assessing cancer risk. This research aligns with the FDA’s mission to “develop and improve scientific approaches that aid in developing new drugs or evaluating their pre-market safety and efficacy.” The AACR Annual Meeting brought together leading experts in cancer research from institutions worldwide, offering a vital platform for engaging stakeholders in regulatory and research initiatives, sharing the latest advancements, and communicating FDA regulations related to oncology and pharmacology toxicology. The meeting also addressed topics such as cell and gene therapy products and provided opportunities to participate in panel discussions in support of the FDA’s commitment to safeguarding public health.
General description of the scientific conference activities:
The American Association for Cancer Research (AACR) Annual Meeting was the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gathered to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlighted the work of the best minds in cancer research from institutions all over the world. FDA attended this meeting to obtain training to understand advances in the field of cancer biology to support FDA/OTP review and regulatory assignments.
19. Parenteral Drug Association AND Food and Drug Administration Joint Regulatory Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, District of Columbia
Conference Start Date: 09/09/2024
Conference End Date: 09/11/2024
Total FDA cost of the conference: $128,739.00
Total number of individuals whose expenses were paid by the FDA: 69
Explanation of how conference advanced the mission of FDA:
International collaboration efforts to improve quality and benefit consumers was highlighted at the Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) Joint Regulatory Conference. FDA attendees speaking at this conference were educating the pharmaceutical industry, which leads to safer and better-quality drug products for consumers. For those attending the conference, it was given to them the opportunity to update their knowledge on current developments in the industry. If the attendance to the conference was not approved, attendees were not able to educate industry or obtain updates that would then be incorporated into their inspections to protect public health. Attendees learned how FDA can continue to optimize its strategies and actions to accomplish its mission to safeguard the quality, safety, and effectiveness of medicines for patients, even with current manufacturing and supply challenges. They also gained knowledge on case studies throughout the meeting and provided real experiences faced by the industry as it strives to adopt these concepts as applied to cell and gene therapy products, providing the FDA perspective on case studies and the health care and developments that adversely impact safety and efficacy of biological drug developments, which produce more efficient drug development and regulatory reliance and resilience during public health.
General description of the scientific conference activities:
The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) Joint Regulatory Conference provided opportunities for attendees to learn about current issues relating to manufacturing and quality assurance. This year's theme was CGMP: Quality Through Science and Innovation. This CGMP conference emphasized the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by diligently managing risks to manufacturing and quality. The vital role of robust quality systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management were emphasized as fundamental to assuring Current Good Manufacturing Practice (CGMP) compliance. Case studies presented throughout the conference provided practical insights and illustrate how sustainable compliance establishes the foundation for quality and supply consistency. Also, FDA experts discussed recent notable inspection findings that led to official action indicated (OAI) decisions and product recalls, as well as PAI withhold decisions.
20. Advamed Medtech Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Anaheim, California
Conference Start Date: 10/09/2023
Conference End Date: 10/11/2023
Total FDA cost of the conference: $127,450.00
Total number of individuals whose expenses were paid by the FDA: 75
Explanation of how conference advanced the mission of FDA:
The high level of attendance at The Advamed Medtech Conference was mission critical because it provided updates and guidance on the latest regulatory guidelines affecting the healthcare industry. It was one of the most important annual regulatory conferences. It brought together key stakeholders that work to innovate medical devices through new regulatory submissions. Attendance at this conference benefited the FDA by providing summary of leadership highlights from the past year and what is forthcoming in 2023/2024. This was consistent with FDA's strategic efforts focused on scientific, yet efficient, product evaluation. FDA attendees heard from leading experts and authorities in the Medical Device field.
General description of the scientific conference activities:
The Advamed Medtech Conference was the largest medical device technical conference each year. The conference provided FDA an opportunity to engage and understand the impact of the current progress of the Case for Quality and advanced manufacturing initiatives. These initiatives were mission critical and supported the FDA ongoing strategic priorities regarding quality and the National Strategy for American Leadership in Advanced Manufacturing. Advamed is a key stakeholder in the development of initiatives operational program, and Medtech was the conference Advamed hosted to provide updates to their constituents. Several updates and changes were provided to that community based on the work of the program this year and release of draft guidance to support the initiatives. Attendance to the conference was mission critical and supported efforts to expand program participation, communicate changes to the stakeholder community, and engage with stakeholders regarding the draft policies issued by FDA. Attendees included experts from regulatory areas that are key stakeholders that work to innovate medical devices patient input, clinical trial design, and ways to innovate device research through quantitative or methodological innovation. The MedTech Conference brought together more than 3,000 attendees to network, conduct business, gain access to capital, and share insights.
21. Infectious Disease Week
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Boston, Massachusetts
Conference Start Date: 10/11/2023
Conference End Date: 10/15/2023
Total FDA cost of the conference: $116,451.00
Total number of individuals whose expenses were paid by the FDA: 38
Explanation of how conference advanced the mission of FDA:
A high level of attendance at Infectious Disease Week was mission critical because the conference is the annual scientific meeting where infectious diseases professionals can meet, share experiences, and develop collaborations. Infection Preventionists (IPs) play a crucial role in keeping the public safe and healthy. In addition to fighting a global pandemic, the infection prevention and control community is protecting us from surges in healthcare-associated infections, measles outbreaks, flu season, and so many other day-to-day infectious battles. This conference was the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS). It was geared toward healthcare professionals in infectious diseases and healthcare epidemiology and prevention, including researchers, clinicians, quality and patient safety practitioners, epidemiologists, and public health officials, including those who see HIV and pediatric patients. It was a mission critical meeting for professionals, who want to stay current and apply state-of-the-art science to clinical care. The material presented at this meeting allowed the attendees to contribute to reviews efficiently and accurately by providing state-of-the-art recommendations. The mission of FDA is to protect and enhance the public health by assuring the availability of safe and effective vaccines and other related biological products. This conference helped FDA employees maintain competence in the knowledge of infectious diseases, which supports FDA’s mission and is considered mission critical to FDA.
General description of the scientific conference activities:
Infectious Disease Week was the must attend event to share services and innovations with the infectious diseases’ community including health care providers, researchers, educators, and public health officials. ID Week featured the latest science and bench to bedside approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases, including HIV, across the lifespan. The event offered healthcare professionals in infectious diseases and related disciplines unparalleled access to credible research and innovative practitioners. It featured sessions that present advances in basic, translational, and clinical research in infectious diseases and healthcare epidemiology, including a focus on HIV and pediatric populations. The meeting provided state-of-the-art updates on key topics and issues.
22. Small Business Regulatory Education for Industry Pharmaceutical Quality Symposium
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Virtual
Conference Start Date: 10/23/2023
Conference End Date: 10/24/2023
Total FDA cost of the conference: $111,239.00
Total number of individuals whose expenses were paid by the FDA: 0
Explanation of how conference advanced the mission of FDA:
The Small Business Regulatory Education for Industry Pharmaceutical Quality Symposium was a major program element for the FDA/CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. This forum allowed FDA to share targeted regulatory information to attendees. This in turn will assist in sponsors submitting more complete application to the FDA, which should ultimately reduce the review time.
General description of the scientific conference activities:
At the Small Business Regulatory Education for Industry Pharmaceutical Quality Symposium, FDA employees presented on FDA's regulatory requirements pertinent to Pharmaceutical Quality with respect to Abbreviated New Drug Application (ANDA), New Drug Application (NDA) and the Biologics License (Application (BLA). The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. SBIA outreach activities include hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic drug, device, and biotechnology industries. CDER SBIA helps empower small businesses in their interactions with FDA and aids those businesses in the development of more complete submissions and first-cycle drug approvals. This conference was designed for one-on-one interaction and was also a virtual on-line format to promote the accessibility of valuable knowledge and expand the number of global attendees. This event targeted small pharmaceutical/devices/biologics business and was widely attended by all levels of industry including small, medium, and large pharma with attendees exhibiting varied levels of expertise.
23. Pharmaceutical Inspection Cooperation Scheme Committee Meeting and Seminar
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Bangkok, Thailand
Conference Start Date: 11/06/2023
Conference End Date: 11/10/2023
Total FDA cost of the conference: $108,665.00
Total number of individuals whose expenses were paid by the FDA: 8
Explanation of how conference advanced the mission of FDA:
As an active member of Pharmaceutical Inspection Cooperation Scheme, including leads on several sub-committees and work groups, it was important for FDA to attend the Pharmaceutical Inspection Cooperation Scheme Committee Meeting and Seminar to participate in voting for new leadership and resolutions. In addition, this helped foster collaboration with our PIC/S and international partners. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises 54 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).
General description of the scientific conference activities:
The Pharmaceutical Inspection Cooperation Scheme Committee Meeting and Seminar focused on a particular aspect of GMP with the aim of providing training and harmonization in the field covered. It was also open to Inspectors from PIC/S Participating Authorities and other interested Medicine Regulatory Authorities.
24. American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Anaheim, California
Conference Start Date: 06/02/2024
Conference End Date: 06/06/2024
Total FDA cost of the conference: $101,874.00
Total number of individuals whose expenses were paid by the FDA: 35
Explanation of how conference advanced the mission of FDA:
Attendees at the American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics were able to hear FDA’s strategic priorities directly from the FDA Commissioner, Chief Counsel, Center Directors, and other key leaders within the Agency. The use of MS assays in clinical labs is growing, and they are being submitted to FDA for review. FDA is involved in early interactions with companies interested in submitting MS assays to FDA, and the Agency has seen an increase in the number of MS assay submissions. FDA has interacted with industry via public workshops, recent publications, collaborations within the FDA (OSEL and NCTR), and myriad outreach efforts to the clinical MS community. It was imperative that, through attending this meeting, FDA continue to develop expertise in the MS field, both technical and practical, by meeting and interacting with practitioners, so that FDA can be (a) prepared to review the devices when they come in, and (b) appropriately advise the community with relevant information pertinent to their concerns. Attending this event benefited FDA by helping the attendees to understand the most current thinking, learning from the experts, and interacting with the attendees, who are developing the devices. This is a critical part of FDA outreach and education.
General description of the scientific conference activities:
A high level of attendance at the American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics was mission critical because this event was held to discuss the scientific and regulatory aspects of applications of mass spectrometry (MS) in clinical laboratories. Mass spectrometry is an analytical tool useful for measuring the mass-to-charge ratio (m/z) of one or more molecules present in a sample. These measurements can often be used to calculate the exact molecular weight of the sample components as well. Typically, mass spectrometers can be used to identify unknown compounds via molecular weight determination, to quantify known compounds, and to determine structure and chemical properties of molecules. The conference provided in-depth discussions and analyses on a wide variety of timely topics by bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia. The discussions presented at this conference were particularly relevant to FDA. The attendees were able to hear different viewpoints and advance understanding in Mass Spectrometry.
25. American Society for Microbiology Microbe
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Atlanta, Georgia
Conference Start Date: 06/13/2024
Conference End Date: 06/17/2024
Total FDA cost of the conference: $101,656.00
Total number of individuals whose expenses were paid by the FDA: 42
Explanation of how conference advanced the mission of FDA:
A high level of attendance at the American Society for Microbiology (ASM) was mission critical because the conference offered education and training in the field microbiology. ASM is a professional organization for scientists who study viruses, bacteria, fungi, algae, and protozoa as well as other aspects of microbiology. ASM has grown into the largest life science professional organization in the world. ASM organizes several large annual meetings, as well as workshops and professional development opportunities for its members. FDA has a responsibility to provide recommendations to sponsors based upon the current state-of-the-art for clinical practice and microbiology. Attending this conference was critical to producing relevant content in pre-submissions and making accurate risk assessments for de novo and PMA product applications. Additionally, learning about laboratories' experiences with new technology allowed attendees to better anticipate potential concerns with emerging technologies and write more robust risk/benefit documents. This conference provided access to real-world data that ultimately helps to uphold FDA's mission of promoting and protecting public health. FDA regulates human and animal food and tests regularly for AMR, pathogens, and viruses. FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply and cosmetics. Testing for certain pathogens is mission critical. This conference was beneficial for the success of FDA in this field of study.
General description of the scientific conference activities:
The American Society for Microbiology (ASM) presented the latest in microbiology technology and clinical practice guidelines. This meeting combined basic microbiology research with clinical infectious disease and antimicrobial therapy, and thus brought together a wide variety of audiences and expanding transdisciplinary approaches to microbiology. This ASM conference was the best place to showcase one’s research, engage with global leaders, and forge new connections with scientists, researchers, and educators. This conference dived deep into groundbreaking discoveries across 8 scientific tracks and tailors your experience with our unique meeting-within-a-meeting format. ASM Microbe delved into critical topics in the microbial sciences that have significant impact on humanity. These sessions went beyond disciplinary boundaries and provided attendees with a comprehensive overview of the latest developments in microbiology and related fields. Attendance at this conference was to gain the insights from world leaders in the fields, to learn the new technology and methods, to exchange scientific findings, and to explore collaborations for the future studies.
26. American Society for Clinical Pharmacology and Therapeutics Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Colorado Springs, Colorado
Conference Start Date: 03/27/2024
Conference End Date: 03/29/2024
Total FDA cost of the conference: $96,251.00
Total number of individuals whose expenses were paid by the FDA: 30
Explanation of how conference advanced the mission of FDA:
The American Society for Clinical Pharmacology and Therapeutics Annual Meeting was the primary forum for member exchange and networking within the ASCPT’s Networks and Communities, which promoted interaction among members, who share this common field of interest. This Conference showcased different aspects of AI used in clinical pharmacology and translational science, including cutting-edge AI tools, commonly used data sources, and successful case studies and applications. This conference featured interdisciplinary teams presenting how AI has improved prediction models in both clinical settings and drug development. Additionally, this conference explored the potential opportunities of using large language models like ChatGPT and other medical foundational models to establish a better paradigm for incorporating AI in clinical pharmacology and drug development. For many years, clinical pharmacologists have been using mathematical models to represent physiological processes and explore the relationships between drugs and changes in PK/PD over time. The rapid advancements in imaging, diagnostics, computing, and communication technologies have created a vast data landscape that clinical pharmacologists now need to navigate.
General description of the scientific conference activities:
Attending the American Society for Clinical Pharmacology and Therapeutics Annual Meeting was responsible for review and analyses of clinical pharmacology data submitted by the tobacco manufacturers in applications for marketing order based on the Substantial Equivalence as well as Modified Risk and Pre-Market Tobacco Product qualifications. Attendance at the American Society of Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting 2024 will keep FDA abreast with the most current advances in the field. This conference met FDA’s mission concerning topics of interest to FDA's medical community. Scientific topics included Clinical Pharmacology Concepts to Address the FDA Recommendation for a Clinical Trial Diversity Plan, Empowering Clinical Pharmacologists, and Translational Scientists Using Artificial Intelligence: Unlocking Potential with Cutting-Edge Use Cases, etc. The ASCPT 2024 Annual Meeting was the premier event in the discipline of pharmacology and translational medicine. It was an outstanding scientific meeting that addressed the latest cutting-edge issues in clinical pharmacology as well as important topic in drug development. This forum focused on the biomarkers that is related to the ongoing research projects, on system pharmacology, smoking related pharmacogenomics (related to health, and physiologic effects of tobacco use, Section 904 of FDCA), on modeling and simulation of exposure, and response data (related to the regulatory review Sections 905, 907, and 910 of FDCA). The ASCPT 2024 conference consisted of clinical pharmacologists, translational scientists, and other scientists in the early phase drug discovery, development, regulatory, and utilization space.
27. American Society of Clinical Oncology Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Chicago, Illinois
Conference Start Date: 05/31/2024
Conference End Date: 06/04/2024
Total FDA cost of the conference: $96,017.00
Total number of individuals whose expenses were paid by the FDA: 31
Explanation of how conference advanced the mission of FDA:
The American Society of Clinical Oncology (ASCO) is a professional organization representing physicians of all oncology subspecialties, who care for people with cancer. The Annual Meeting brought together more than 30,000 oncology professionals from around the world to discuss state of the art treatment modalities, new therapies, and ongoing controversies in the field. These topics were mission relevant and informed the attendees as a reviewer on emerging public health issues in Cancer arena. All sessions were critically relevant to the reviews conducted in FDA. The conference provided an opportunity to learn and become current on the state of art in clinical oncology practices and the diagnostic and therapeutic advances occurring in the field. A high level of attendance was mission critical as attending will greatly enhance the ability of all attendees to effectively review submissions and performance of their duties at the FDA.
General description of the scientific conference activities:
The American Society of Clinical Oncology (ASCO) Annual Meeting offered informative educational and scientific sessions that highlighted the latest in cancer care treatments, such as Clinical Science Symposia, Education Sessions, Extended Education Sessions, Meet the Professor Sessions, and Clinical Problems in Oncology Sessions. Attendees at this conference learned the latest advances in clinical oncology and changes in patient care that are currently being planned and implemented. The latest in Oncology diagnostic and treatments based on precision medicine principles were scheduled to be discussed at the conference. The conference discussed personalized medicine paradigms currently being tested in melanoma, lymphoid leukemia, and real time molecular genetic profiling that is being employed in clinical trials currently.
28. American Public Health Association Annual Meeting and Expo
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Atlanta, Georgia
Conference Start Date: 11/12/2023
Conference End Date: 11/15/2023
Total FDA cost of the conference: $93,981.00
Total number of individuals whose expenses were paid by the FDA: 43
Explanation of how conference advanced the mission of FDA:
A high level of attendance at the American Public Health Association Annual Meeting and Expo was mission critical because the conference brought the public health community together to experience robust scientific programming, networking, social events, poster sessions, and more. The APHA Annual Meeting and Expo was the premier public health event of the year, offering innovative and exciting opportunities that offered engagement with public health experts, collaboration with other public health advocates, and the opportunity to grow professionally. This annual meeting helped to establish a stronger public health infrastructure, helped to expand essential prevention and health promotion efforts at the community, state and federal levels, and worked to tackle threats from communicable diseases. Attendance to this conference was extremely beneficial for all FDA attendees in all departments.
General description of the scientific conference activities:
The American Public Health Association Annual Meeting and Expo was the premier public health event of the year offering innovative and exciting opportunities to help one reach one’s personal and professional goals. It provided unparalleled opportunities to learn from the latest public health research and practice, especially those related to COVID-19. It assessed leading public health tools and services, expand professional networking, and select from hundreds of CE accredited educational sessions presented by top thought leaders discussing industry trends, emerging issues, and proven methods. The attendees also were offered the most current information and tools and training to assure that attendees are up to date in current public health trends and topics in public health.
29. FDA Foods Program Regulatory Science Conference
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: College Park, Maryland
Conference Start Date: 09/10/2024
Conference End Date: 09/11/2024
Total FDA cost of the conference: $93,795.00
Total number of individuals whose expenses were paid by the FDA: 68
Explanation of how conference advanced the mission of FDA:
The objective of this project is the development of a regulatory method, encompassing the recovery, detection, identification, and quantification of microbial pathogens from foods to provide the laboratory science for FDA’s regulatory, policy, and compliance and enforcement programs. The FDA Foods Program Regulatory Science Conference was in support of the mission of FDA by the sharing of up-to-date research and technology methods with others to educate and protect the public health. This meeting advanced the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. The interaction with scientists, regulators, and policy makers from academia, industry and federal/state regulatory partners was essential to effectively complete the regulatory food safety mission.
General description of the scientific conference activities:
Attendees for the FDA Foods Program Regulatory Science Conference presented research at the conference. This meeting included poster sessions that highlighted the research across CVM, ORA, NCTR, and the CFSAN Centers of Excellence. The conference also planned to include presentations by prominent speakers from federal government, academia, consumer groups, international regulatory agencies, and industry. The conference offered an opportunity to showcase the important, mission-relevant research being carried out across the Foods Program and provided a platform for FDA staff to share their technical expertise and network with colleagues.
30. 65th American Society of Hematology Annual Meeting and Exposition
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 12/09/2023
Conference End Date: 12/12/2023
Total FDA cost of the conference: $89,435.00
Total number of individuals whose expenses were paid by the FDA: 30
Explanation of how conference advanced the mission of FDA:
The purpose of attending the 65th American Society of Hematology Annual Meeting and Exposition was to receive scientific education on real-world use of emerging immunotherapies and the interplay between immunology, hematology, and coagulation in infectious diseases. FDA reviews the safety and effectiveness of devices designed for use in autoimmune diseases (among others). As technologies advance, medical devices are getting more and more complex, and training in the development of new technologies and new devices in immunological disease diagnosis and understanding the correlation between device design and device performance are critical to fulfilling FDA’s mission. Furthermore, attendees included industry representatives, and thus, attendance improved communication/networking and promoted FDA's strategic goal of improving customer service. This was critical to engage stakeholders for regulatory and research activities and exchange the latest information and disseminate FDA regulations as it pertains to the field of hematology evaluation, which is in support of the FDA mission in protecting human health and regulated product review work.
General description of the scientific conference activities:
The American Society of Hematology Annual Meeting and Exposition allowed attendees to gain knowledge and receive fostering high-quality, equitable care, transformative research, and innovative education to improve the lives of patients with blood and bone marrow disorders that will benefit FDA. Attending this conference allowed attendees to learn and understand challenges to assist with their regulatory review assignments within FDA. The review work within the FDA requires awareness and knowledge of the updates in the scientific aspects of hematology. The annual meeting organized by the American Society of Hematology provided invaluable educational experience and the opportunity to review updates in the hottest topics in hematology. Attending this meeting enhanced scientific/technical, clinical, and professional skills, and thus enhanced job-related duties to promote and protect the public health.
31. Electronic Drug Registration and Listing Using CDER Direct
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Virtual
Conference Start Date: 09/12/2024
Conference End Date: 09/12/2024
Total FDA cost of the conference: $89,214.00
Total number of individuals whose expenses were paid by the FDA: 0
Explanation of how conference advanced the mission of FDA:
The Electronic Drug Registration and Listing Using CDER Direct meeting was a major program element for the FDA/CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. This meeting also was of invaluable assistance to both the CDER and SBIA staff, as it will serve as reference and training material to help direct them in producing relevant material responsive to their audience's inquiries and needs.
General description of the scientific conference activities:
The Electronic Drug Registration and Listing Using CDER Direct was dedicated to assisting the industry with creating complete and accurate registration and listing submissions. This forum allowed FDA to share targeted regulatory information and updates. This in turn assisted regulatory affairs professionals working on registration and listing (or whoever will submit Structured Product Labeling (SPL) to FDA) in submit more efficient and complete data to the FDA.
32. Association of Food and Drug Officials Annual Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Grand Rapids, Michigan
Conference Start Date: 06/09/2024
Conference End Date: 06/12/2024
Total FDA cost of the conference: $85,767.00
Total number of individuals whose expenses were paid by the FDA: 41
Explanation of how conference advanced the mission of FDA:
Attendance at the Association of Food and Drug Officials Annual Conference promoted public health by supporting the agency's mission of helping safe and effective products reach the market, and helping the public obtain accurate, science-based information to improve health. The conference addressed drug/cannabis policies and regulations that affect the security background investigation process. The AFDO conference brought together national and international subject matter experts on more than 40 topics in food manufacturing, food retail, produce, cannabis, and body art. Participation in the AFDO Conference allowed attendees to interact with a variety of leaders and experts in the food manufacturing, food retail, and produce. AFDO’s Annual Educational Conference was an exceptional opportunity to learn and network with both peers and a diverse selection of passionate subject matter experts in food and cannabis. During the conference, the AFDO Annual Educational Conference was the center of the food safety world for professionals from government, states, academia, consumer groups, and manufacturing. The Cannabis Product Committee mission statement is to develop and implement informed policy strategy for protecting the health of consumers of FDA-regulated cannabis products.
General description of the scientific conference activities:
The 128th Association of Food and Drug Officials (AFDO) Annual Educational Conference (AEC) was held annually to provide information on current and emerging food, agriculture, and drug topics impacting health and safety and to build consensus among states on regulatory approaches to address them. Representatives from government, industry, states, and the public were invited to participate, and this conference presented a valuable opportunity to liaise with industry officials and stay informed on critical topics impacting our regulatory mission. Attendance at this in-person only event was mission critical for the Office of State Cooperative Programs (OSCP). The AFDO conference partnered with regional AFDO affiliates to present this learning experience in a different geographic area annually. Subject matter experts convened for the educational conference ready and willing to share their knowledge. These were dozens of national and international experts on more than 40 topics in food manufacturing, food retail, produce, cannabis, and body art. AFDO also hosted pre-conference in-depth workshops and training opportunities on a broad number of topics adjacent to the annual conference.
33. American College of Toxicology 44th Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Orlando, Florida
Conference Start Date: 11/12/2023
Conference End Date: 11/15/2023
Total FDA cost of the conference: $85,492.00
Total number of individuals whose expenses were paid by the FDA: 40
Explanation of how conference advanced the mission of FDA:
The mission of the American College of Toxicology is to educate, lead, and serve scientists by promoting an exchange of information and perspectives on safety assessment and new developments related to applied toxicology. The American College of Toxicology 44th Annual Meeting elicited and exchanged information as well as disseminated FDA regulations as it pertains to the field of toxicology, which was in support of the FDA mission in protecting human health. Attendees gained knowledge and exchanged information and perspectives on safety assessment and new developments related to applied toxicology. Also attendees were able to engage in networking and marketing opportunities with toxicologists, industry consultants, and other professionals, which was beneficial to the FDA mission. Attendance positively impacted upon the FDA workload, its initiatives, mission, and goals by advancing and increasing the regulatory science knowledge of FDA staff in the areas of toxicology that will enhance and support the quality of the staff's regulatory review of tobacco product applications. Higher quality FDA reviews were directly benefited as the agency can now more efficiently complete its reviews on time and with higher quality. Therefore, the impact ultimately decreases the workload.
General description of the scientific conference activities:
The American College of Toxicology 44th Annual Meeting was a global community of professional scientists representing the pharmaceutical and biotech industries, regulatory agencies, contract research organizations, academia, and consulting firms. This gathering brought together a community of toxicologists at small venues conducive to idea exchange, professional networking, and continuing education. The Annual Meeting included a wide-ranging scientific program and educational courses, with distinguished plenary speakers. The purpose of attending this conference was to enhance scientific expertise needed by the agency and learn of new methods and approaches in toxicological sciences that are applicable to tobacco product regulatory review. In addition, the purpose of attending the conference was to keep abreast of scientific strategies that could be proposed by applicants to reduce harm caused by tobacco use. Consequently, this knowledge exchange at the conference was useful for enhancing knowledge development and decision-making, which is a goal of the FDA. Moreover, the research that will be presented at the conference allowed FDA to better understand the relevance of toxicology methods for assessing the risk profile of tobacco products being reviewed at the Office of Science.
34. Joint Statistical Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Portland, Oregon
Conference Start Date: 08/03/2024
Conference End Date: 08/08/2024
Total FDA cost of the conference: $84,900.00
Total number of individuals whose expenses were paid by the FDA: 35
Explanation of how conference advanced the mission of FDA:
The Joint Statistical Meeting (JSM) was the largest annual gathering of statisticians in North America. A high level of FDA attendance at JSM was mission critical because this conference provided a unique opportunity for agency statisticians (of whom there are at least several hundred) to update their skills and hear about new methodological developments. Also attending this conference kept FDA abreast of current issues in the application of statistics to regulatory science as well as research science. This conference was designed to communicate with leaders in the areas of statistics from academia, industry, and regulatory sections. This was an effective meeting to gather current information and interact with experts. The JSM statistics forum addressed statistical challenges in drug development and was critical to FDA’s biostatisticians staying current on statistical issue in regulatory science in fulfillment of FDA's mission. Attendance connected FDA with other statisticians/data scientists/operational research analysts in the world to stay on the cutting edge of the techniques and practices in resource capacity planning. This was particularly critical given the increasing use of (and support for, under PDUFA VII) of complex and innovative clinical trial designs and other novel statistical approaches to regulatory science. It was also a much-needed opportunity for professional development following an unusually isolated period during the height of the COVID-19 pandemic.
General description of the scientific conference activities:
The Joint Statistical Meeting was a broad conference with topics ranging from statistical applications to methodology and theory to the expanding boundaries of statistics, such as analytics and data science, which benefited FDA mission. JSM encompassed a range of events, including technical sessions on a very broad range of statistical topics, short courses, roundtable discussions, and other learning opportunities. This also offered a unique opportunity for statisticians in academia, industry, and government to exchange ideas and explore opportunities for collaboration. The Joint Statistical Meeting was where all the statisticians from all fields get together to exchange new ideas and recent developments, including statistical methods for innovative clinical trials to evaluate the safety and effectiveness of medical products including medical devices. By attending this meeting, employees were able to learn new statistical methods for medical device evaluation, especially methods for leveraging real world data in regulatory decision making. Those learnings helped improve the efficiency of regulatory submission review with real world evidence, helping meet the MDUFA goals. Attendance benefited medical device user fee agreement (MDUFA)/prescription drug user fee agreement (PDUFA) guidance development as well as training related to new MDUFA commitments.
35. International Conference on Pharmacoepidemiology Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Berlin, Germany
Conference Start Date: 08/24/2024
Conference End Date: 08/28/2024
Total FDA cost of the conference: $80,295.00
Total number of individuals whose expenses were paid by the FDA: 23
Explanation of how conference advanced the mission of FDA:
Participants in the International Conference on Pharmacoepidemiology Annual Meeting learned about the advancing the health of the public by providing a global forum for the open exchange of scientific information and for the development of policy, education, and advocacy for the field of pharmacoepidemiology, including such areas as pharmacovigilance, drug utilization research, comparative effectiveness review, and therapeutic risk management. The conference also allowed FDA to fulfill its mission in providing the public with information to promote the safe and appropriate use of biological products. This helped advance the health of the public by providing a global forum for the open exchange of scientific information and for the development of policy, education, and advocacy for the field of pharmacoepidemiology, including such areas as pharmacovigilance, drug utilization research, comparative effectiveness review, and therapeutic risk management.
General description of the scientific conference activities:
The International Conference on Pharmacoepidemiology Annual Meeting provided new insights into the current issues and associated challenges impacting drug safety, focusing primarily on drug products, and biologics, throughout all phases of development and marketed use. Top pharmaceutical, biotech, and regulatory representatives, who are experts in their field, discussed new and updated legislation in various ISPE regions, important new harmonization initiatives, risk management life-cycle, benefit-risk assessment, PROs, the impact of social media, and the use of other data sources and observational research. Also multiple FDA staff members gave presentations at the conference. The presentations at the 40th ICPE highlighted the FDA's work related to protecting public health by ensuring the safety, efficacy, and security of biological products such as vaccines.
36. Well Characterized Biotechnology Products Symposium
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, District of Columbia
Conference Start Date: 01/23/2024
Conference End Date: 01/25/2024
Total FDA cost of the conference: $76,830.00
Total number of individuals whose expenses were paid by the FDA: 78
Explanation of how conference advanced the mission of FDA:
Attendees for the Well Characterized Biotechnology Products Symposium heard from and engage with thought leaders on a wide range of topics including CMC development strategies, innovative analytical characterization, global submission strategies, next-generation therapeutics and vaccines, as well as the challenges and promises of CRISPR-based therapeutics, which are poised to revolutionize the future of medicine. This was an informative Symposium where attendees were able to network, collaborate, and expand their knowledge.
General description of the scientific conference activities:
The Well Characterized Biotechnology Products Symposium established a reputation as the highest-regarded annual conference addressing the role of current and emerging CMC analytical technology among evolving US and international regulatory perspectives. The regulatory expertise unique to the FDA was essential to the effective communication of such technology and its applications.
37. American Society Quality World Conference for Quality and Improvement
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 05/12/2024
Conference End Date: 05/15/2024
Total FDA cost of the conference: $74,979.00
Total number of individuals whose expenses were paid by the FDA: 30
Explanation of how conference advanced the mission of FDA:
The American Society Quality World Conference for Quality and Improvement was a great opportunity for FDA to learn in the area of Organization Quality Management and Process Improvement. FDA was able to discover emerging best practices in leadership and engagement, diversity/equity/inclusion, change management and more in this series of expert-led sessions, offering keys to leading and affecting change in both the near and long term. Attendees learned how an organization can build a system of quality processes that exceed customer expectations, cultivate a leader’s mentality, ensure a culture of inclusion and equity, and embrace innovation. Attendance also allowed employees to learn how to hire, develop and be part of a strong quality team and communicate the value of quality across your organization. Attendees learned how to leverage quality and quality professionals to prepare organizations to be resilient to the ever-changing environment organizations are tackling now and in the future. Attendance at this conference enhanced the attendee’s ability to meet the FDA mission.
General description of the scientific conference activities:
The American Society Quality World Conference for Quality and Improvement included topics such as emerging management and leadership practices; motivating teams and team building; recruitment and retention; multiple generations in the workplace; supervisory skills; training, education, and development; change management, closing the leadership gap, leadership in the 21st century, transformational leadership, social responsibility, and sustainability. Knowledge is always key in completing any mission, and at this conference attendees learned how to fortify essential quality methodologies within their teams while preparing to meet future challenges with sustainable quality solutions, consumers benefit. Building on its legacy of innovation and improvement, the quality community was well positioned to reinforce the essentials, which are total quality management, continuous improvement, ISO standards, data integration, and to embrace emerging, universal concepts, including culture, diversity and ESG (environmental, social, and governance). At the meeting, attendees learned how quality processes and methodologies bolster their organizations’ response to risks like supply chain, economic pressures, and global volatility, as well as help spark a culture of excellence and a sustainable, strong foundation for success. The conference explored the symbiotic relationship between human and scientific aspects of quality management. Attendance allowed employees to gain new knowledge from quality practitioners conducting training sessions and workshops and new insights about what has changed in quality management. The conference brought together thousands of professionals representing manufacturing, consulting, health care, government, education, aerospace, and more for 3 plus days of learning that will produce long-term gains in an organization’s quality mission. From emerging quality practitioners to experienced professionals, WCQI 2024 offered meaningful networking, education, and product discovery to help individuals and organizations pursue excellence through quality.
38. Produce Safety Consortium
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: St. Louis, Missouri
Conference Start Date: 11/07/2023
Conference End Date: 11/09/2023
Total FDA cost of the conference: $70,622.00
Total number of individuals whose expenses were paid by the FDA: 37
Explanation of how conference advanced the mission of FDA:
The National Association of State Departments of Agriculture (NASDA) is a high-profile grantee that focuses on agriculture. NASDA hosts quarterly meetings to provide an opportunity to deliver status of work in accordance with RFA-FD-19-23 “National Project to Support and Promote Consistent Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” FDA officials, NASDA (the awardee), State Cooperative Universities and selected State Produce Safety Cooperative Agreement awardees attend this face-to-face meeting which gives partners an opportunity to expand upon their collaborative efforts and negotiate best practices moving forward in the implementation of the produce safety program in accordance with the Produce Safety Rule. The National Association of State Departments of Agriculture (NASDA) enhances American food and agricultural communities through policy, partnerships, and public engagement. This event of the Produce Safety Consortium brought a wide array of presentations, resources, and opportunities to share and collaborate with federal, state, university, and organizational partners. The consortium enhanced capabilities as produce safety programs continue to develop and grow. This conference was mission critical conference because the National consortium provided education and outreach to states, stakeholders, industry, and regulators where updates are made, changes are discussed, and topics from the past and for the future are brought up.
General description of the scientific conference activities:
This was for NASDA’s Annual Produce Safety Consortium, in which NASDA represents the elected and appointed commissioners, secretaries, and directors of the departments of agriculture in all fifty states and four U.S. territories. NASDA brought in their entire membership from all 50 states to participate in this annual meeting. NASDA was a critical stakeholder group that FDA worked closely with them on food policy related issues, our partnerships with the States, and other key public engagement activities. This conference was important to foster stakeholder engagement on the Produce Safety Rule and offered an opportunity to provide consistent technical advice for the successful implementation of FSMA’s Produce Safety Rule (PSR). These activities supported FDA’s mission to protecting public health.
39. American Thoracic Society International Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 05/17/2024
Conference End Date: 05/22/2024
Total FDA cost of the conference: $68,811.00
Total number of individuals whose expenses were paid by the FDA: 19
Explanation of how conference advanced the mission of FDA:
The American Thoracic Society International Conference attracted a diversity of public health professionals committed to best practices and policies to reduce tobacco use, which is the leading preventable cause of disease and death in the United States. The ATS Tobacco Action Committee, a focused subgroup of the organization, meets annually as part of the conference and works with FDA in areas of tobacco research and tobacco control. FDA's targeted exhibit program was designed to expand awareness of FDA's regulatory activities and enhance stakeholder relationships. Also, it was the ideal place for registered nurses, advanced practice nurses, respiratory therapists, and hospitalists to discuss their experiences, challenges, and research, so that all can learn about the latest advances in understanding pulmonary disease, critical illness, and sleep disorders.
General description of the scientific conference activities:
The American Thoracic Society International Conference was the home of pulmonary, critical care, and sleep professionals. Each year, nearly 14,000 of these professionals choose to attend, present, and learn about the latest advances, meet with colleagues from around the world, and strike new collaborations. The conference was multidisciplinary. Clinicians and researchers in many other fields attended the conference, thereby enriching conversations that led to insights that ultimately improve patient care. The role of tobacco in the development, management, and treatment of pulmonary diseases was an important focus of the conference. The ATS International Conference gathered the entire health care team in one place to share ideas across these medical and scientific disciplines. It was an excellent place to connect with many candidates at one time, and thus have a high return on investment for the time spent. The Mission of the ATS is, “To accelerate global innovation in the advancement of respiratory health through multidisciplinary collaboration, education, and advocacy.” The conference presented the latest clinical evidence on mechanical ventilation, critical care monitoring, and pulmonary intervention, and support devices.
40. Association of American Feed Control Officials Midyear Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Chattanooga, Tennessee
Conference Start Date: 01/23/2024
Conference End Date: 01/25/2024
Total FDA cost of the conference: $66,903.00
Total number of individuals whose expenses were paid by the FDA: 47
Explanation of how conference advanced the mission of FDA:
Attendance at the Association of American Feed Control Officials Midyear Meeting advanced the mission of the agency (as greater than 70% of FDA field work is to ensure the safety of animal food is done by our State partners, who are all members of AAFCO). FDA has several regulations and initiatives that are being launched, including Food Safety Modernization Act, Veterinary Feed Directive, and animal feed labelling. State partners would be unable to implement, monitor, and inspect for compliance within FDA regulations without the knowledge and skills being presented by FDA employees. The Burden of compliance and enforcements would fall to FDA's limited resources likely leading to preventable distribution of adulterated animal food products recognize.
General description of the scientific conference activities:
The Association of American Feed Control Officials Midyear Meeting (AAFCO) brought together government, industry, and academia to provide first-hand information about current and emergent issues related to animal feed products. Also, the conference disseminated relevant information along with discussion of important topics, such as methods of analysis that ensure the safety and integrity of foods, proficiency testing programs, and other products that impact the industry. Businesses can met the scientific community, scientists built professional expertise and shared best practices, and regulators leveraged stakeholder collaboration to improve compliance and public safety. This was a true opportunity to network and collaborate with peers from organizations, institutions, non-profits, and academia.
41. Transcatheter Cardiovascular Therapeutics
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Francisco, California
Conference Start Date: 10/23/2023
Conference End Date: 10/26/2023
Total FDA cost of the conference: $66,085.00
Total number of individuals whose expenses were paid by the FDA: 26
Explanation of how conference advanced the mission of FDA:
A high level of attendance at the Transcatheter Cardiovascular Therapeutics (TCT) was mission critical because the conference was the annual scientific conference where cardiovascular professionals met, shared experiences, and developed collaborations. Attendance allowed FDA employees to be able to provide updates to industry with updates regarding the new CDR Total Product Life Cycle Advisory Program. Also, by attending it allowed employees to stay updated in the field of cardiovascular therapeutics and other related devices. The meeting featured late-breaking clinical trials and science, case-based presentations, practical educational forums, hands-on training, and limitless opportunities for learning and networking with peers and key opinion leaders from around the globe.
General description of the scientific conference activities:
The Transcatheter Cardiovascular Therapeutics conference was a premier conference dedicated to the treatment of structural heart disease via transcatheter aortic valve replacement and transcatheter mitral and tricuspid therapies, which represents the most active and dynamic innovation area in the field of interventional cardiology. At this conference, the organizer and the FDA jointly hosted two Town Hall sessions focusing on some emerging topics related to transcatheter valvular therapies, which required FDA in-person attendance. The Director of OHT2 (Cardiovascular Devices) collaborated with stakeholders present about a special FDA Town Hall Session with other FDA leadership on emerging topics in this area.
42. American College of Clinical Pharmacology Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Rockville, Maryland
Conference Start Date: 09/08/2024
Conference End Date: 09/10/2024
Total FDA cost of the conference: $63,945.00
Total number of individuals whose expenses were paid by the FDA: 49
Explanation of how conference advanced the mission of FDA:
The American College of Clinical Pharmacology Annual Meeting provided dozens of educational workshops/symposiums, including topics related to drug development, drug dosing, etc. FDA worked closely with industry for drug development and usage. Attending this conference helped attendees stay in the forefront of their field with a series of high-quality, relevant educational events designed to meet the needs of the global clinical pharmacology community.
General description of the scientific conference activities:
A global audience in the American College of Clinical Pharmacology Annual Meeting heard presentations from 99 Faculty Speakers, who participated in a Pre-meeting Workshop, Trends in Drug Development Seminar, the Plenary Session, and 17 Symposia on a series of topics ranging from research and drug development to patient care. The Invited keynote Jack Yanovski, MD, PhD gave an engaging presentation on "How Precise Is Current Pharmacotherapy for Pediatric & Adolescent Obesity?" Additionally, 167 scientific Posters were presented by authors from around the world.
43. American Chemical Society Fall National Meeting and Exposition
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Denver, Colorado
Conference Start Date: 08/18/2024
Conference End Date: 08/22/2024
Total FDA cost of the conference: $63,636.00
Total number of individuals whose expenses were paid by the FDA: 28
Explanation of how conference advanced the mission of FDA:
The American Chemical Society Fall National Meeting and Exposition meeting was one of the largest conferences that hosts many chemistry professionals to meet and share their ideas and advances in the field, including medicinal chemistry, biological chemistry, etc. This meeting helped to expand attendees’ subject knowledge and better supported the FDA mission. The conference enhanced ways to leverage unprecedented opportunities for stakeholder collaboration on complex testing and analysis challenges, helping improve compliance and public safety. ACS was the preeminent conference in the field of medicinal chemistry, and presenting at this meeting in-person was critical for engaging with more potential collaborators for precision FDA, which is a mission critical program.
General description of the scientific conference activities:
Work for FDA attendees involves reviewing the chemistry, manufacturing, and controls (CMC) information of different types of drugs, so it was very beneficial for attendees to attend the American Chemical Society Fall National Meeting and Exposition. Attendees learned about recent advances in process development and manufacturing of biologics, challenges in developing new modalities, and emerging biophysical and analytical technologies. The ACS Meeting & Exposition was where chemistry professionals meet to share ideas and advance scientific and technical knowledge. At this conference, attendees shared ideas and advanced scientific and technical knowledge, and by attracting thousands of chemical professionals, the meeting provided excellent opportunities for sharing chemistry, connecting with one of the world's largest scientific societies, and advancing attendees’ careers in this ever-changing global economy. ACS Meetings & Expos are the perfect blend of information, practical knowledge, and networking opportunities. From technical sessions, career development, networking, student programming, and more, the ACS Fall 2024 had something for everyone.
44. American Pharmacists Association Annual Meeting and Exposition
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Orlando, Florida
Conference Start Date: 03/22/2024
Conference End Date: 03/25/2024
Total FDA cost of the conference: $60,604.00
Total number of individuals whose expenses were paid by the FDA: 23
Explanation of how conference advanced the mission of FDA:
At the American Pharmacists Association Annual Meeting and Exposition, each attendee was encouraged to amplify their voice and impact, not only on patient health, but also on the mental well-being of fellow pharmacists and to champion fair compensation for critical services and advocate for diversity in pharmacy. Pharmacists are directly impacted by FDA’s policies, specifically, FDA’s GFI#256 Compounding Animal Drugs from Bulk Drug Substances. This was an opportunity for outreach and education with one of FDA key public health stakeholders. Animal drug compounding policies are a priority for FDA and the work supports FDA’s commitment to safe animal drugs as well as FDA’s mission to protect human and animal health. Attendance advanced the mission of the agency by providing a FDA update to partners and stakeholders on FDA’s GFI#256 Compounding Animal Drugs from Bulk Drug Substances support of FDA’s mission to protect human and animal health will help us to continue to collaborate with stakeholders to ensure animal drug safety.
General description of the scientific conference activities:
The American Pharmacists Annual Meeting was the largest association of pharmacists in the United States, with more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians as members. APhA is the organization whose members are recognized in society as essential in all patient care settings for optimal medication use that improves health, wellness, and quality of life. Through information, education, and advocacy, APhA empowered its members to improve medication use and advance patient care. This year’s theme was Unleashing the Power of Pharmacy, and it was designed to empower pharmacists to embrace their role as change agents and help revolutionize the profession.
45. Association for the Advancement of Blood & Biotherapies Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Nashville, Tennessee
Conference Start Date: 10/14/2023
Conference End Date: 10/17/2023
Total FDA cost of the conference: $60,169.00
Total number of individuals whose expenses were paid by the FDA: 27
Explanation of how conference advanced the mission of FDA:
The Association for the Advancement of Blood & Biotherapies Annual Meeting (AABB) was the premier conference for the blood and biotherapies community. The AABB biotherapies community transformed patient care. They drove policies to ensure patient access, expanding coverage for transformative therapies, advancing novel biotherapies research, and increasing the supply and safety of biological products. Together, this community was leading the discovery, development, and delivery of innovative outcomes. This annual Conference joined colleagues from throughout the world to connect, network, learn, and advance the fields of blood and biotherapies. It was also mission critical that the agency continue to participate in the workshops to further the education of the industry and other regulatory counterparts for a uniform understanding of the laws and regulations, enhance compliance, and strengthen donor eligibility knowledge. There was cooperative educational structure established by the organization and its conference for all attendees.
General description of the scientific conference activities:
A high level of attendance at the Association for the Advancement of Blood & Biotherapies Annual Meeting (AABB) was mission critical because the conference offered education and training in the field blood and biotherapies. It provided in-depth discussions and analyses on a wide variety of timely topics by bringing together experts from the federal government, industry, non-profit, patient and consumer advocates, consulting organizations, and academia. Attendees were able to hear and learn the most current information regarding the latest practices in blood banking needed to effectively review and approve submissions for blood and blood components/products. FDA attendees had an active role in the conference, participating in educational sessions, including one on “Inspection Findings and Updates from FDA’s Office of Regulatory Affairs – Where Does Your Institution Rank Regarding the Most Cited Deficiencies?”
46. International Forum on Process Analytical Chemistry Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: North Bethesda, Maryland
Conference Start Date: 03/03/2024
Conference End Date: 03/06/2024
Total FDA cost of the conference: $59,945.00
Total number of individuals whose expenses were paid by the FDA: 43
Explanation of how conference advanced the mission of FDA:
Attendees attended the International Forum on Process Analytical Chemistry Annual Meeting for powerful sessions, expert speakers, exhibition, and numerous networking opportunities. This highly anticipated annual conference included engaging presentations, cutting edge technological and regulatory solutions, case studies, best practices, panels, and roundtable discussions from regulators, industry leaders, academia, and solution providers across the globe. Therefore, this conference provided a great opportunity for FDA’s attendees to exchange ideas and collaborations to further scientific and medical innovations and brought industry, regulators, academics, and patients together to co-create, problem-solve, and discuss global and local challenges facing professionals in the life sciences community. This in-person conference was necessary to support of the agency's mission to protect public health by leveraging FDA processes that can improve drug quality, address shortages of medicines, and speed time-to-market.
General description of the scientific conference activities:
Process Analytical Technology is one of the most exciting and important advanced technology areas meeting both the current challenges, as well as the future needs of industry. Each year the International Forum on Process Analytical Chemistry Annual Meeting consists of industry, regulatory, and academic leaders working collaboratively to create a comprehensive program that addresses important mainstay topics, as well as the latest trends, technologies and applications. The IFPAC brought together experienced professionals and the next generation of leaders to share in discussions, give input, and get ideas for the future well-being of the industry. The IFPAC was the essential meeting place for the latest developments in Process Analytical Technology, Quality by Design, and overall process monitoring and control within the Pharmaceutical, Biotechnology, Food, Chemical, Petrochemical & related industries. The IFPAC 2024 focused around creating a framework for the future of advanced manufacturing quality and innovation. Many Advanced Manufacturing (AM) topics, such as Industry 4.0/Pharma 4.0/Digital Manufacturing, Continuous Manufacturing (CM), Distributed Manufacturing (DM) and Point of Care manufacturing (PoC), emerging technologies, and regulatory expectations were discussed this year. Therefore, this conference provided a great opportunity for FDA’s AM group to exchange of ideas and collaborations to further scientific and medical innovations and will bring industry, regulators, academics, and patients together to co-create, problem-solve, and discuss global and local challenges facing professionals in the life sciences community.
47. Pittcon Conference and Exposition
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 02/24/2024
Conference End Date: 02/28/2024
Total FDA cost of the conference: $59,440.00
Total number of individuals whose expenses were paid by the FDA: 23
Explanation of how conference advanced the mission of FDA:
Attendance at the Pittcon Conference and Exposition advanced the mission of the agency, providing in-depth understanding in latest advances in analytical research and scientific instrumentation, and this was critical for FDA's scientific reviews on animal feed ingredients. This in turn facilitated the FDA mission on safeguarding human and animal health. FDA's attendance at this meeting was also critical to advance the FDA scientific review process of animal feed ingredients for ensuring safe animal food. Advancing and enriching scientific endeavor by connecting scientists worldwide, facilitating the exchange of research and ideas, showcasing the latest in laboratory innovation, and funding science education and outreach were essential key aspects for FDA attendance.
General description of the scientific conference activities:
The purpose of the Pittcon Conference and Exposition was to inform and teach new methodologies as well as improve technical skills related to analytical instrumentation that are used in the FDA Labs. By attending PITTCON, FDA scientists were able to network and establish rapport with scientists and develop new ideas to improve our laboratory methods. This conference also provided attendees with an opportunity to meet with scientists to exchange ideas and analytical methods, which are critical to the future of the FDA. This conference supported the FDA's mission by keeping analysts informed and up-to-date on current laboratory methods performed that protect the public health. If unable to attend this conference, FDA scientists would have missed the opportunity to learn about state-of-the-art practices and network with fellow scientists. This conference was an excellent platform to exchange ideas and experiences and learn from attendees from across the industry and academia. The theme for this meeting was Discovering, Producing, and Marketing Innovative Drugs, Therapies, and Medical Devices.
48. Society of Photographic Instrumentation Engineers Medical Imaging
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 02/18/2024
Conference End Date: 02/22/2024
Total FDA cost of the conference: $57,102.00
Total number of individuals whose expenses were paid by the FDA: 17
Explanation of how conference advanced the mission of FDA:
Attendance at the Society of Photographic Instrumentation Engineers Medical Imaging allowed attendees to comment on ongoing research efforts and potentially build new collaborations that align with FDA’s regulatory science and regulatory approaches around AI/ML and new research related to video-based AI//ML. SPIE Medical Imaging 2024 topics directly aligned with FDA’s regulatory science programs and attendance gave employees an opportunity to communicate FDA's latest thinking on AI/ML device evaluation while attending the conference.
General description of the scientific conference activities:
Attendance at the Society of Photographic Instrumentation Engineers Medical Imaging provided the employees with an opportunity to learn about the latest activities and research findings associates with medical AI/ML and especially novel application areas that may be future products coming to FDA for review and subsequent marketing. Attendees were able to discover the latest advances in image processing, physics, computer-aided diagnosis, perception, image-guided procedures, biomedical applications, ultrasound, informatics, radiology, digital pathology, and more at the SPIE Medical Imaging Conference. Each year this important community comes together to share and discuss current research, hear the latest breakthroughs, and connect with colleagues.
49. International Association for Food Protection European Symposium
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Geneva, Switzerland
Conference Start Date: 04/30/2024
Conference End Date: 05/02/2024
Total FDA cost of the conference: $56,994.00
Total number of individuals whose expenses were paid by the FDA: 7
Explanation of how conference advanced the mission of FDA:
Attending the International Association for Food Protection European Symposium IAFP's European Symposium provided a food safety forum for the exchange of ideas with colleagues from across Europe working in industry, government, and academia. The Symposium was an excellent forum to gain knowledge about the latest developments and techniques in food science and safety, which aligns with the FDA mission.
General description of the scientific conference activities:
FDA presented on Metagenomics at this International Association for Food Protection European Symposium IAFP's European Symposium. Attending the International Association for Food Protection European Symposium IAFP's European Symposium provided a food safety forum for the exchange of ideas with colleagues from across Europe working in industry, government, and academia. The Symposium was an excellent forum to gain knowledge about the latest developments and techniques in food science and safety, which aligns with the FDA mission.
50. American Society of Health System Pharmacists Mid-Year Clinical Meeting and Exhibition
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Anaheim, California
Conference Start Date: 12/03/2023
Conference End Date: 12/07/2023
Total FDA cost of the conference: $56,502.00
Total number of individuals whose expenses were paid by the FDA: 18
Explanation of how conference advanced the mission of FDA:
Attending the American Society of Health System Pharmacists Mid-Year Clinical Meeting and Exhibition was beneficial to FDA as it provided current information on drug topics directly related to RPM role from Agency and industry perspective. Information and insight gained from this conference was also beneficial for application management activities and provided up to date regulatory guidance to sponsors.
General description of the scientific conference activities:
The American Society of Health System Pharmacists Midyear Clinical Meeting and Exhibition had more than 20,000 pharmacy professionals and students from all over the globe come together. It was the biggest exchange of pharmacy expertise, ideas, and innovation in the world.
51. American Academy of Dermatology Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Denver, Colorado
Conference Start Date: 03/08/2024
Conference End Date: 03/12/2024
Total FDA cost of the conference: $54,400.00
Total number of individuals whose expenses were paid by the FDA: 15
Explanation of how conference advanced the mission of FDA:
The panel sessions and presentations at the American Academy of Dermatology Annual Meeting was directly relevant to FDA's work as reviewers of dermatological devices, including wound dressings and dermal fillers. The content presented at the conference included sessions about the state of the art in clinical dermatology practice as well as educational sessions about different topics in dermatology. The American Contact Dermatitis Society is one of the largest and most prestigious professional physician groups in the United States, using drug and cosmetic products. Attendees participating in the American Academy of Dermatology Annual Meeting learned about the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails. Attendance advocated high standards in clinical practice, education, and research in dermatology as well as supporting and enhancing patient care for a lifetime of healthier skin, hair, and nails.
General description of the scientific conference activities:
The American Academy of Dermatology Annual Meeting was one where dermatologists from all over the United States and the world come to share information, have discussions, and get training. Often the information is very new. New items of information (including new safety signals, efficacy results, etc.) about items such as biologics were often discussed in open meetings with comments from acknowledged world-wide experts. There was an extensive poster session again with brand new information, and there were opportunities to discuss posters with the authors. This meeting was an unique opportunity to search out information about known products under development and hear about other products under development that have not yet come to our attention. The conference offered an opportunity to network and engage with the dermatology community, which will assist in FDA regulatory oversight to ensure device safety and effectiveness, as well as promotion of innovation and technology advancement. The information to be conveyed in the session provided updates to members, who include physicians, academics, industry, and other professionals, about the Modernization of Cosmetics Regulation Act (MoCRA) and the implications of the provisions for their practices and product development. By not attending the conference, the attendees would not have received updated information and would not have been able to discuss concerns with the regulators.
52. 18th Workshops on Recent Issues in Bioanalysis
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Antonio, Texas
Conference Start Date: 05/06/2024
Conference End Date: 05/10/2024
Total FDA cost of the conference: $53,632.00
Total number of individuals whose expenses were paid by the FDA: 21
Explanation of how conference advanced the mission of FDA:
The 18th Workshops on Recent Issues in Bioanalysis presented the best and most comprehensive program of the year with the most innovative scientific talks from industry leaders and the latest advice from regulators (with WRIB traditional interactive regulators' sessions) to provide the best learning, interacting, and networking opportunity. This workshop advanced the mission of the agency by improving the understanding of technologies and methods for evaluating biologics and novel therapeutics, which is critical to approving safe and effective drug products and protecting human and animal health.
General description of the scientific conference activities:
The 18th Workshops on Recent Issues in Bioanalysis program provided FDA with novel case studies and emerging approaches because it was the only program built on White Paper recommendations/consensus from the previous years to ensure no repetitions of same discussions but a continuous evolution of Science & Regulations & Technology applications. The purpose for attending this conference was to maintain current on the most recent advances in bioanalysis of biologics and novel therapeutics in areas related to the evaluation of immunogenicity and the immune response. This scientific workshop helped enhance reviewers' knowledge in the technology and methods for evaluating the effects and characteristics of drug products and to support the process for reviewing the safety and effectiveness of drug products. White papers published as the result of discussions during these workshop sessions were directly used for harmonization across regulatory agencies and industry and were used to aid the review of biologics and novel therapeutics.
53. Parenteral Drug Association Pharmaceutical Microbiology Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, District of Columbia
Conference Start Date: 10/02/2023
Conference End Date: 10/04/2023
Total FDA cost of the conference: $51,895.00
Total number of individuals whose expenses were paid by the FDA: 51
Explanation of how conference advanced the mission of FDA:
The Parenteral Drug Association (PDA) Pharmaceutical Microbiology Conference addressed the future challenges of microbiology in today's global pharmaceutical market. The conference covered the best practices, development of standards, and the integration of innovative technologies. This was critical to engage stakeholders for regulatory and research activities as well as exchange the latest information and disseminate FDA regulations as it pertains to the field of microbiology while participating on the task force, which was in support of the FDA mission in protecting human health.
General description of the scientific conference activities:
The Parenteral Drug Association (PDA) Pharmaceutical Microbiology Conference continued the ongoing tradition of addressing the opportunities and challenges, most relevant, to the future of microbiology in today's global market. New and seasoned professionals from all facets of the field, including global industry, academia, and regulatory authorities, shared insights on how to best prepare for the future through the sharing of best practices, development of standards, and integration of innovative technologies.
54. Microphysiological Systems World Summit
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Seattle, Washington
Conference Start Date: 06/10/2024
Conference End Date: 06/14/2024
Total FDA cost of the conference: $53,181.00
Total number of individuals whose expenses were paid by the FDA: 17
Explanation of how conference advanced the mission of FDA:
The Microphysiological Systems World Summit included tissue and organ-on-chips as well as promising innovative alternative methodologies being used for the evaluation of the safety of chemicals and medical products and could serve as a replacement for some aspects of animal research and become an integral part of drug development. Attendance to this conference was absolutely critical in order to learn more about development, manufacture, validation, and use of these innovative systems prior to stakeholders proposing their incorporation into development plans. Attendance advanced the mission of the agency as it was consistent with HHS Strategic Goal 4 (specifically Objective 4.2: Invest in the research enterprise) and the scientific workforce to maintain leadership in the development of innovations that broadened FDA’s understanding of disease, healthcare, public health, and human services resulting in more effective interventions, treatments, and programs.
General description of the scientific conference activities:
Microphysiological systems comprise a number of bioengineering breakthroughs that reproduce organ architecture and function in vitro. Fueled by stem-cell technologies, a broad variety of especially human models and test systems have emerged, which make relevant experimental tools broadly available through intel and multidisciplinary collaborations. Conference series are a key tool to form community and accelerate scientific developments, their implementation and global harmonization. The Microphysiological Systems World Summit provided an overview on the state-of-the-art in such dynamic and diverse fields, enabling transfer learning. A global conference on MPS was identified by opinion leaders in the field as a key step forward in the maturation and harmonization of the area. A series of annual MPS World Summits is critical to present the latest scientific achievements, discuss the advances and challenges, and enable communication between young and newly interested scientists.
55. Regulatory Affairs Professionals Society Convergence
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Montreal, Canada
Conference Start Date: 10/03/2023
Conference End Date: 10/05/2023
Total FDA cost of the conference: $50,464.00
Total number of individuals whose expenses were paid by the FDA: 47
Explanation of how conference advanced the mission of FDA:
The Regulatory Affairs Professionals Society Convergence was the largest global organization of and for those involved with the regulation of healthcare and related products including medical devices, pharmaceuticals, biologics, and nutritional products. Founded in 1976, the Regulatory Affairs Professionals Society helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offered education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities, and other valuable resources, including Regulatory Affairs Certification, the only post-academic professional credential to recognize regulatory excellence. The purpose of FDA attendance was to provide presentations and case studies to communicate FDA requirements and expectations with regards to drug manufacturing and data integrity in drug manufacturing. If FDA did not attend, the industry would not fully understand what FDA expects. This would potentially result in facilities that are not compliant with the required regulations associated with drug manufacturing or the corresponding requirements for data integrity.
General description of the scientific conference activities:
FDA attendance to the Regulatory Affairs Professionals Society Convergence allowed FDA to reach out with Complex Innovative Trial Designs. The outreach on the FDA Complex Innovative Trial Designs was to fulfill PDUFA VI requirements aim at bring drugs faster to the patient as well as to ensure the safety of drug and biologics by reaching out to the Regulatory Affairs Professional Society (RAPS). RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. The gathering brought together representatives of industry, regulatory bodies, research, academia, and clinical organizations that are directly involved in managing the regulatory process and aligning science, regulation, and business strategy. Attendance allowed attendees to obtain current skills and strategies across the medical device, biotech, and pharmaceutical sectors. Also it allowed attendees to obtain additional knowledge about product development, decision-making, and regulatory applications in industry for professional development.
56. American Chemical Society Spring
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: New Orleans, Louisiana
Conference Start Date: 03/17/2024
Conference End Date: 03/21/2024
Total FDA cost of the conference: $49,671.00
Total number of individuals whose expenses were paid by the FDA: 17
Explanation of how conference advanced the mission of FDA:
The American Chemical Society Spring conference had speakers and attendees from the industry and academia, single-use final product (e.g. bags, assemblies) manufacturers, film/resin manufacturers as well as keynote speakers from the biopharmaceutical industry, experts in polymers/materials science, and manufacturers of novel biomedical devices. Attendance advanced the mission of the agency as the ACS Annual Spring Meeting was the premier conference for chemists in the U.S. Attending the ACS conference was a valuable opportunity for Bioanalytical Chemistry Subject Matter Experts (SMEs) to gain current knowledge on scientific approaches to quantitative measurement of xenobiotics. This conference provided critical knowledge that will aid our SMEs in the conduct of their evaluations required under FDA's regulations. These evaluations are required in the regulations as part of the process for approval of new animal drug applications. It was also expected that a broader scope of experts from industry, academia, and other U.S. and international agencies would be in attendance, which provided an opportunity for our SMEs to gain contacts in international agencies, academia, and industry. Without attendance, the capabilities of the SMEs to carry out these mission-critical activities would have been severely diminished.
General description of the scientific conference activities:
The American Chemical Society Spring conference covered a variety of research topics and software, which are critical to developing better and faster methods in supporting FDA’s mission of monitoring illegal drug residues in food producing animals. Attendance also allowed FDA to keep up-to-date with current techniques and instrumentations as well as FDA was allowed to contribute to method development and validation of veterinary drug residues in various matrices. Attendees at this conference shared a passion for chemistry, connecting with one of the world's largest scientific societies, and advancing career in this ever-changing global economy. The conference relates to FDA's mission by providing information to review applications as well as to deliver safe and effective drugs to the public.
57. Respiratory Drug Delivery
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Tucson, Arizona
Conference Start Date: 05/05/2024
Conference End Date: 05/09/2024
Total FDA cost of the conference: $49,003.00
Total number of individuals whose expenses were paid by the FDA: 18
Explanation of how conference advanced the mission of FDA:
Part of the FDA’s mission is to protect the public health, which is providing assurance of product safety and efficacy, and (within the context of generics) this means ensuring an equivalent product performance between a generic and its reference product. For complex products like orally inhaled drug products, demonstrating bioequivalence can be challenging for drug developers, and so it is important that FDA’s expectations and current scientific thinking regarding bioequivalence was communicated effectively. The low global warming propellant transition is a complex and challenging issue for generic and brand name product developers, and so any clarity on the Agency’s understanding regarding the critical bioequivalence studies to support or the applicable regulatory submission pathway will aid development of these products. Therefore, a presentation on these topics at the Respiratory Drug Delivery addressed these considerations and helped fulfill FDA’s mission.
General description of the scientific conference activities:
This was the latest Respiratory Drug Delivery conference in a series that has ran continuously since 1988 and garnered a sustained reputation for excellent content covering all aspects of drug delivery to the lungs and nose. In-depth presentations and discussion of pioneering science in tandem with exceptional opportunities for networking appealed to scientists, engineers, regulators, clinicians, solutions providers, and business professionals active in this exciting field.
58. American Society of Access Professionals National Training
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Anaheim, California
Conference Start Date: 06/03/2024
Conference End Date: 06/05/2024
Total FDA cost of the conference: $48,359.00
Total number of individuals whose expenses were paid by the FDA: 14
Explanation of how conference advanced the mission of FDA:
The American Society of Access Professionals National Training conference enabled its members and business partners to collaborate, exchange ideas, develop professionally, and advocate the effective use of information management to improve government information issues and increasing the professionalization of its membership throughout the communities they serve. Attendance at ASAP's NTC was a critical piece to the success of the FDA/ORA FOIA program. It was the only advanced training and networking opportunity solely for access professionals. It was an excellent opportunity to meet and collaborate with other federal agencies as well as engage with frequent requestors to leverage successes, receive feedback, and consider improvements.
General description of the scientific conference activities:
The American Society of Access Professionals (ASAP) National Training conference provided access to educational, interactive, and highly motivational workshops that are specific to the major missions of the Division of Information Disclosure (DID). By not attending this robust conference, the attendees would have missed out on invaluable techniques that would have enhanced their jobs and the Division. The DID programs are Center-wide programs that could be a loss for the FDA/CDRH, if they were unable to attend. The ability for the DID employee to attend this conference directly correlates to the FDA mission of protecting public health since the records that are reviewed require the attendees to be up-to-date on the FOIA, Privacy, and Records management for the FDA.
59. Parenteral Drug Association India Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Hyderabad, India
Conference Start Date: 03/11/2024
Conference End Date: 03/15/2024
Total FDA cost of the conference: $46,698.00
Total number of individuals whose expenses were paid by the FDA: 9
Explanation of how conference advanced the mission of FDA:
Attendance at the Parenteral Drug Association India Annual Meeting fulfilled agency goals to participate and educate external stakeholders on programs deemed of high importance to FDA and HHS. It also fulfilled agency goals to participate in research and/or science-based activities deemed of high importance to HHS as well as to provide technical assistance in support of FDA strategic goals with FDA global stakeholders. This conference provided a collaborative opportunity to engage and interact with the regional stakeholders involved in public health activities.
General description of the scientific conference activities:
The 2024 Parenteral Drug Association India Annual Meeting discussed topics focusing on medical devices, environmental monitoring, aseptic processing, inspectional trends on cleaning validation/cross contamination issues and findings, compliance, and remediations issues. Attendees heard firsthand from the inspectors and compliance decision makers and ultimately those officials, who inspect and review responses that affect industry for many years. Participants also heard from Industry subject matter experts on innovative technology, data integrity, internal audits and aseptic line design in addition to other critical topics that support quality. Attendees had an opportunity to select a track or session topics to participate in and share their views during interactive case studies and breakout group discussions. The 2024 PDA India Chapter Annual Meeting and Workshop continued to focus on critical topics and allowed for an even broader audience.
60. Biotechnology Innovation Organization International Convention
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Diego, California
Conference Start Date: 06/03/2024
Conference End Date: 06/06/2024
Total FDA cost of the conference: $46,570.00
Total number of individuals whose expenses were paid by the FDA: 12
Explanation of how conference advanced the mission of FDA:
The SES team serves as a liaison between stakeholder organizations and the public to address policy priorities and initiatives. At the Biotechnology Innovation Organization International Convention, FDA reached out to enhance external stakeholder relations with medical device groups, including BIO, the host of the BIO International Convention 2024 conference. Attending this conference strengthened liaison skills, increase knowledge about biotechnology/medical devices, digital health, patient advocacy, and also provided an opportunity to build relationships with the biotechnology community. The conference aligned with FDA strategic plan policy area II that calls for leveraging innovation and competition to improve health care, broaden access, and advance public health goals. Attendance at this conference enabled attendees to meet (to introduce our licensable inventions) with biotech entities (potential licensees) and executives, who are key decision makers in the licensing process.
General description of the scientific conference activities:
The Biotechnology Innovation Organization International Convention was the largest and most comprehensive event for biotechnology, representing the full ecosystem of biotech with over 20,000 industry leaders from across the globe. Whether one works at a public pharmaceutical company, biotech startup, academia, non-profits, and government or is a researcher, business development professional, or investor, BIO is where they made valuable connections and built relationships.
61. China International Food Safety and Quality Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Beijing, China
Conference Start Date: 11/02/2023
Conference End Date: 11/03/2023
Total FDA cost of the conference: $46,167.00
Total number of individuals whose expenses were paid by the FDA: 10
Explanation of how conference advanced the mission of FDA:
The 17th Annual China International Food Safety and Quality Conference was an important top-level event that brought together food safety professionals across China and from around the world for two intensive days of learning and networking. It was an educational program that featured a distinguished faculty of regulatory, scientific, academic, and industry leaders, who were putting food safety into action, and who were there to learn advancements and changes in food safety and food culture. There was a benefit for the FDA China Office investigators, relations specialist, management, and one LE Staff to attend to experience and learn about novel approaches in these realms. Additionally, FDA and the American Chamber of Commerce members were able to hold a meeting during the conference to collaborate and further discuss on trade, food safety culture, and other pertinent topics. Safe food is essential to achieving sustainability, security, and above all, good health. This challenging job benefits immensely from multilateral knowledge sharing, collaboration, and dialogue.
General description of the scientific conference activities:
With a focus on professional education and networking, the 17th Annual China International Food Safety and Quality Conference brought a passionate community of global experts together to address critical issues and identify recent advances in science, intelligent technologies, and effective best practices that can make a difference towards improving food safety. At the event in Beijing, up to 1,000 regulators, scientists, industry executives, technologists, and academics, who are committed to protecting food and consumers, were expected to attend, including 120 plus talented food safety thought leaders, who took the stage to share their insights on the latest developments.
62. Association of American Feed Control Officials Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: San Antonio, Texas
Conference Start Date: 08/07/2024
Conference End Date: 08/09/2024
Total FDA cost of the conference: $45,944.00
Total number of individuals whose expenses were paid by the FDA: 25
Explanation of how conference advanced the mission of FDA:
Attendance at the Association of American Feed Control Officials (AAFCO) Annual Meeting advanced the agency's mission, as over 70% of FDA field work ensuring the safety of animal food was conducted by state partners, who are all AAFCO members. With new regulations and initiatives such as FSMA, VFD, and animal feed labeling being implemented, state partners relied on the knowledge and skills shared by FDA employees to effectively monitor compliance and conduct inspections. Without this collaboration, the burden of enforcement would have fallen solely on FDA’s limited resources, potentially leading to the preventable distribution of adulterated animal food products. The three-day AAFCO Annual Meeting facilitated communication and collaboration with state partners to support the Animal Feed Regulatory Program Standards (AFRPS) and the Preventive Controls Cooperative Agreement. During the meeting, the Board of Directors and committee members voted on new legislation, regulatory principles, definitions, or amendments to existing policies. Discussions focused on advancing a nationally integrated feed safety system, maintaining best practices, and enhancing the safety of human and animal food. Additionally, the Cooperative Agreement provided funding for laboratories supporting animal feed programs and pursuing or expanding accreditation under ISO/IEC 17025. AAFCO membership comprised state agencies that were awardees of FDA contracts and cooperative agreements related to animal feed. Attending the meeting was critical for FDA representatives to cast their votes, network, and collaborate with state partners. This event directly supported FDA’s mission by protecting public health, strengthening science, improving product quality, enhancing partnerships, and fostering effective communication.
General description of the scientific conference activities:
AAFCO was a key regulatory partner in ensuring the safety of animal feed. Members of AAFCO, comprising state animal feed regulatory officials, were responsible for maintaining feed safety within their states under FDA contracts and cooperative agreements. These officials performed inspections and feed analyses on behalf of the FDA. As an AAFCO member, the FDA’s partnership with the organization played a vital role in fulfilling its mission and supporting the Partnership for Food Protection (PFP) to ensure the safety of the animal food supply and edible products for human consumption. The AAFCO Feed Administrators Seminar, held annually, provided a platform for FDA and state feed safety officials to convene and address critical regulatory issues. This meeting allowed federal and state members to collaborate in developing and implementing uniform and equitable model laws, regulations, standards, definitions, and enforcement policies governing the manufacture, distribution, and sale of animal feeds. The Association of American Feed Control Officials (AAFCO) Annual Meeting, a three-day event, facilitated communication and collaboration with state partners to advance the objectives of the Animal Feed Regulatory Program Standards (AFRPS) and the Preventive Controls Cooperative Agreement. During the meeting, the Board of Directors and committee members voted on new legislation, regulatory principles, definitions, and amendments to existing policies. Discussions focused on fostering a nationally integrated feed safety system, maintaining best practices, and improving the safety of human and animal food. The Cooperative Agreement also provided funding for laboratories supporting animal feed programs and working toward or expanding accreditation under ISO/IEC 17025.
63. American Society of Cataract & Refractive Surgery Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Boston, Massachusetts
Conference Start Date: 04/05/2024
Conference End Date: 04/08/2024
Total FDA cost of the conference: $43,172.00
Total number of individuals whose expenses were paid by the FDA: 11
Explanation of how conference advanced the mission of FDA:
The American Society of Cataract and Refractive Surgeons annual meeting focused on new clinical and technical topics in ophthalmology. Attendance at this conference enabled scientific reviewers to stay updated on the latest advancements in their device areas, directly influencing the review practices within the Ophthalmic Division of the FDA. This event supported the FDA’s mission by exploring new ideas and innovations, providing opportunities to refresh clinical knowledge, and facilitating engagement with peers on the latest research in ophthalmology.
General description of the scientific conference activities:
The American Society of Cataract and Refractive Surgeons annual meeting focused on therapeutic, surgical, and administrative topics directly relevant to ASCRS and ASOA members. The event included symposia, lectures, workshops, sessions, courses, and skills transfer labs, providing anterior segment surgeons, practice managers, administrators, technicians, and nurses with opportunities to maintain and enhance their clinical and administrative expertise.
64. American Academy of Neurology Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Denver, Colorado
Conference Start Date: 04/13/2024
Conference End Date: 04/18/2024
Total FDA cost of the conference: $41,718.00
Total number of individuals whose expenses were paid by the FDA: 12
Explanation of how conference advanced the mission of FDA:
The American Academy of Neurology Annual conference hosted over 300 courses, enabling attendees to maintain CHEs in the field of neurology. Attendance enhanced employee knowledge and aligned with the FDA's mission to protect and promote public health by ensuring quality drugs for the American public. Attendees gained updated information on neurology and its impact on various diseases, providing valuable insights and updates critical to the FDA's mission. FDA participated to support the program’s purpose of accelerating the development and broad patient access to safe, effective, high-quality medical devices of public health importance, which was directly aligned with the FDA’s mission.
General description of the scientific conference activities:
The American Academy of Neurology (AAN) Annual Conference was an exciting and diverse event, offering a wide array of top-tier education across various topics and specialties, valuable CME opportunities, cutting-edge scientific advancements, and a platform to connect with colleagues from around the world. The 2023 AAN Annual Meeting provided innovative and creative experiences throughout the week, fostering discussions, addressing advancements in science, and exploring the use of neurological devices. The event covered topics ranging from basic science to clinical trials and the latest therapies, serving as a forum for continuous neuroscientific learning, networking, and discovery. This attendance was mission-critical as it facilitated engagement with patient and physician groups, payors, industry representatives, academia, innovators, investors, and other agencies. The AAN Annual Meeting, as the largest gathering of neurologists and neuroscience professionals, offered unparalleled education, the latest scientific discoveries, and numerous opportunities to connect with colleagues worldwide.
65. 16th Annual FDA AdvaMed Medical Device Statistical Issues Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, District of Columbia
Conference Start Date: 04/02/2024
Conference End Date: 04/03/2024
Total FDA cost of the conference: $40,871.00
Total number of individuals whose expenses were paid by the FDA: 62
Explanation of how conference advanced the mission of FDA:
By attending the 16th Annual FDA AdvaMed Medical Device Statistical Issues Conference, employees interacted and engaged with thought leaders influencing the development, evaluation, and use of medical devices to enhance health outcomes. They gained knowledge of cutting-edge methodologies, practices, and policies, enhancing their ability to fulfill the FDA's mission of protecting and promoting public health.
General description of the scientific conference activities:
The 16th Annual FDA AdvaMed Medical Device Statistical Issues Conference covered important regulatory topics and brought together key stakeholders dedicated to advancing medical device innovation through new regulatory submissions. Discussions focused on patient input, clinical trial design, and innovative approaches to device research through quantitative and methodological advancements, all of which were critical to the field.
66. American Statistical Association Biopharmaceutical Section Regulatory
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Rockville, Maryland
Conference Start Date: 09/25/2024
Conference End Date: 09/27/2025
Total FDA cost of the conference: $40,730.00
Total number of individuals whose expenses were paid by the FDA: 185
Explanation of how conference advanced the mission of FDA:
The American Statistical Association Biopharmaceutical Section Regulatory provided an intimate forum for attendees to engage with leading experts in the field, discussing novel statistical approaches and regulatory considerations related to real-world data. This knowledge and discussion advanced the FDA’s mission by supporting the appropriate use of real-world evidence in oncology product development to facilitate patient-centered regulatory decision-making. Attending this conference allowed employees to gain insights into industry perspectives on statistical issues encountered in reviewing sponsor submissions. It also provided updates on the latest statistical methodologies to enhance regulatory evaluations in medical devices, including cardiovascular medical devices focusing on hierarchical composite endpoints (HCE) and advances in propensity score methodology. These advancements directly supported the efficient use of statistical approaches in regulatory evaluations.
General description of the scientific conference activities:
The American Statistical Association Biopharmaceutical Section Regulatory Workshop was originally established as a meeting for FDA statisticians and later expanded to include all statisticians interested in practices related to areas regulated by the FDA. Although the workshop achieved attendance of more than 1,000 statisticians in 2022, it maintained its grassroots planning approach. By featuring both FDA and industry speakers in each session, the conference preserved its original intent while adding value through the inclusion of academic speakers and representatives from other regulatory agencies. The workshop included discussions on cardiovascular medical devices, focusing on hierarchical composite endpoints (HCE), and advances in propensity score methodology, including approaches to assess comparability between pediatric and adult groups and methods to augment pediatric data. The event also offered opportunities for attendees to network and collaborate through the DIA education committee, planning and organizing statistical webinars. These activities created a highly relevant conference for statistical practitioners in the biopharmaceutical field.
67. Tobacco Science Research Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Atlanta, Georgia
Conference Start Date: 09/08/2024
Conference End Date: 09/11/2024
Total FDA cost of the conference: $39,802.00
Total number of individuals whose expenses were paid by the FDA: 43
Explanation of how conference advanced the mission of FDA:
Attendance at the 77th Tobacco Science Research Conference directly supported FDA’s mission by providing lab personnel with insights into cutting-edge science, potential public health risks, and innovative harm reduction strategies. This knowledge informed regulatory decisions and policies, enabling science-based actions to protect public health. The conference also offered updates on the latest developments in the regulation of current and emerging tobacco products, which are critical to the FDA’s ongoing efforts to regulate the manufacture, distribution, and marketing of tobacco products. As the sole Tobacco Products Laboratory providing analytical support for the Center for Tobacco Products, participation was essential to facilitate effective regulatory action and guidance. Missing this conference would have hindered the FDA’s ability to stay informed on critical information necessary for shaping effective tobacco product regulation.
General description of the scientific conference activities:
The 77th Tobacco Science Research Conference brought together a wide range of participants, including tobacco control regulators, leading academic scientists, researchers, and other nicotine stakeholders. The conference offered diverse opportunities to share information through presentations, abstract posters, and discussions. Presenters ranged from TMA and ITG Brands to universities sharing their findings on tobacco-related topics. The event focused on science, technology, policy, and topics related to harm reduction in the tobacco industry. It provided updates on the latest trends and developments in the tobacco industry and innovative technologies, as well as advancements in tobacco control policy and regulations. This annual event offered a platform to apply current research findings and best practices in tobacco control to enhance the effectiveness of these activities in the U.S. Attendees gained a comprehensive understanding of innovative technologies and scientific advancements shaping the industry, ensuring they remained informed and equipped to address emerging challenges.
68. Chemistry Manufacturing and Controls Strategy Forum North America
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Gaithersburg, Maryland
Conference Start Date: 07/16/2024
Conference End Date: 07/17/2024
Total FDA cost of the conference: $39,690.00
Total number of individuals whose expenses were paid by the FDA: 42
Explanation of how conference advanced the mission of FDA:
The Chemistry Manufacturing and Controls (CMC) Strategy Forum North America provided significant benefits to the FDA by offering a platform for biotechnology and biological product discussions on relevant CMC issues throughout a product’s lifecycle. The forum fostered collaborative technical and regulatory interactions, advancing discussions toward consensus concepts. These efforts directly supported the FDA’s mission by integrating good scientific practices with good regulatory practices, ultimately improving the regulation and oversight of biotechnology products for public health.
General description of the scientific conference activities:
The Chemistry Manufacturing and Controls (CMC) Strategy Forum North America earned its reputation as the premier scientific meeting for regulatory, industry, and academic professionals to address emerging CMC issues in biotechnology. The forum employed an open and transparent workshop format to facilitate meaningful discussions. Participants worked collaboratively to explore key issues, align on consensus concepts, and share outcomes that benefit both industry and regulatory agencies. This event successfully merged scientific and regulatory practices, fostering mutual understanding and progress in the field.
69. Integrated Foodborne Outbreak Response and Management
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, District of Columbia
Conference Start Date: 01/22/2024
Conference End Date: 01/24/2024
Total FDA cost of the conference: $39,203.00
Total number of individuals whose expenses were paid by the FDA: 32
Explanation of how conference advanced the mission of FDA:
Attendance at the Integrated Foodborne Outbreak Response and Management (InFORM) Conference supported the FDA’s mission by providing critical knowledge to improve surveillance systems and practices for detecting, investigating, and controlling enteric disease outbreaks. It enabled attendees to advance the prevention and control of disease, disability, and death caused by foodborne, waterborne, and environmentally transmitted infections. FDA representatives, including those from Vet-LIRN and the Division of One Health Monitoring, gained valuable insights into foodborne illness in animals, zoonotic pathogens, and antimicrobial resistance. This knowledge directly supported the agency’s efforts to improve animal food safety and promote the One Health concept, particularly through initiatives like the National Antimicrobial Resistance Monitoring System. Networking and collaboration with public health professionals further enhanced FDA’s capacity to address food safety and outbreak response.
General description of the scientific conference activities:
The Integrated Foodborne Outbreak Response and Management (InFORM) Conference brought together public health officials, including environmental health specialists, epidemiologists, laboratory scientists, health communicators, and federal, state, and local professionals, to address foodborne and enteric disease outbreak response. Held every two years, the conference featured a keynote speaker, plenary and discipline-specific sessions, and poster presentations, maximizing the use of travel funds. Participants discussed strategic goals, shared best practices, and exchanged expertise on improving surveillance systems and outbreak response practices. The conference also highlighted the One Health concept, emphasizing the interconnectedness of human, animal, and environmental health. Sessions explored topics such as antimicrobial resistance and foodborne illness in animals, creating opportunities to enhance skills, promote collaboration, and support public health initiatives.
70. Heart Rhythm Society Scientific Sessions
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Boston, Massachusetts
Conference Start Date: 05/16/2024
Conference End Date: 05/19/2024
Total FDA cost of the conference: $38,112.00
Total number of individuals whose expenses were paid by the FDA: 15
Explanation of how conference advanced the mission of FDA:
Attendance at the Heart Rhythm Society (HRS) Scientific Sessions was mission-critical as it focused on devices spanning the entire division, including ablation devices, implantables, electrophysiology, and digital health. Employees gained valuable knowledge about heart rhythm disorders, a significant public health problem, and the latest epidemiological, scientific, and treatment recommendations for these conditions. This information enhanced their ability to evaluate and regulate atrial fibrillation devices effectively. The conference directly supported FDA’s mission by equipping employees with insights into the latest technological developments in implantable electrophysiology devices. These advancements were critical for reviewing the increasing number of new devices being developed to treat heart rhythm disorders, which affect millions of Americans and increase the risk of stroke, heart failure, and other cardiovascular complications. Participation also strengthened professional skills, particularly for premarket lead reviewers, ensuring informed and science-based regulatory evaluations.
General description of the scientific conference activities:
The Heart Rhythm Society (HRS) Scientific Sessions served as the premier scientific meeting for major advances in cardiovascular science and healthcare. The conference highlighted cutting-edge developments in the management of heart rhythm disorders, focusing on technology advancements for implantable electrophysiology devices. As the largest and most recognized annual gathering of global regulatory affairs professionals, the event brought together representatives from industry, regulatory bodies, research, academia, and clinical organizations. Over four days, stakeholders and decision-makers participated in professional development, discussions, and relationship-building activities. The conference fostered collaboration and alignment between science, regulation, and business strategy. By presenting the latest research and innovations, the HRS Scientific Sessions provided attendees with opportunities to stay current with advancements in cardiovascular device technology and apply this knowledge to their work in regulatory science.
71. The 31st Conference on Retroviruses and Opportunistic Infections
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Denver, Colorado
Conference Start Date: 03/03/2024
Conference End Date: 03/06/2024
Total FDA cost of the conference: $37,759.00
Total number of individuals whose expenses were paid by the FDA: 13
Explanation of how conference advanced the mission of FDA:
Attendance at the 31st Conference on Retroviruses and Opportunistic Infections (CROI) advanced the FDA’s mission by providing critical knowledge on emerging issues related to HIV pathogenesis and related infectious diseases. The conference addressed various aspects of HIV infection, including HIV replication, in vivo establishment, immunopathogenesis, and strategies for controlling and eradicating infection. This knowledge enhanced the ability of attendees in clinical pharmacology and biostatistics to stay informed on the latest developments and integrate cutting-edge research into regulatory science. Such advancements directly supported the FDA’s role in protecting public health by improving oversight of HIV-related treatments and addressing opportunistic infections in patients with AIDS.
General description of the scientific conference activities:
The 31st Conference on Retroviruses and Opportunistic Infections (CROI) was the premier international event for exploring the latest studies, significant developments, and innovative research methods in HIV and related infectious diseases. The conference featured groundbreaking original research on HIV, as well as key findings on SARS-CoV-2 and the m-pox virus. In-person attendees engaged in interactive sessions and explored rich poster presentations on topics such as retroviruses, HIV replication, and immunopathogenesis. CROI bridged basic science and clinical investigation, focusing on translating research findings into clinical practice in the field of HIV and related viruses. The conference provided a comprehensive overview of HIV infection, ranging from fundamental virology to immunological responses and therapeutic strategies. By participating, attendees gained insights into cutting-edge advancements, equipping them to address challenges in HIV research and care effectively.
72. Cardiovascular Research Technologies
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, District of Columbia
Conference Start Date: 03/09/2024
Conference End Date: 03/12/2024
Total FDA cost of the conference: $37,261.00
Total number of individuals whose expenses were paid by the FDA: 8
Explanation of how conference advanced the mission of FDA:
Attendance at the Cardiovascular Research Technologies (CRT) conference advanced the FDA’s mission by equipping employees with knowledge of current and emerging practices, devices, and industry trends in cardiovascular technology and procedures. This increased understanding improved the Heart Valves Team's ability to review devices and provide informed consultations to colleagues, directly supporting the FDA’s goal to protect and enhance public health. Gaining insights into the evolving field of valvular therapies was critical for refining the team’s review processes and ensuring effective regulatory oversight of these technologies.
General description of the scientific conference activities:
The Cardiovascular Research Technologies (CRT) conference is a premier annual event focused on the discussion and dissemination of clinical data regarding new and approved cardiovascular devices and procedures for physicians. The event provided valuable educational opportunities on the latest advancements in valvular therapies, electrophysiology (EP), and broader cardiovascular technologies. By fostering a deeper understanding of the field’s growth and evolution, CRT supported participants in staying current with industry practices and trends, helping them apply this knowledge in their professional roles.
73. Conference Name
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Basel, Switzerland
Conference Start Date: 03/03/2024
Conference End Date: 03/08/2024
Total FDA cost of the conference: $36,782.00
Total number of individuals whose expenses were paid by the FDA: 3
Explanation of how conference advanced the mission of FDA:
Attendance at the International Council for Harmonisation (ICH) E6 (R3) conference advanced the FDA’s mission by supporting the development of internationally harmonized guidelines aimed at ensuring the efficient and cost-effective development and registration of safe, effective, and high-quality medicines. By participating in the working groups, FDA/CDER experts contributed to preventing duplication of clinical trials and enhancing public confidence in the protection of subjects during clinical trials. This collaboration ensured alignment with global standards and facilitated the availability of safe and effective medicines for patients worldwide.
General description of the scientific conference activities:
The International Council for Harmonisation E6 (R3) conference brought together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. Reflecting the increasingly global nature of drug development, ICH held biannual meetings to advance harmonization efforts in areas of Safety, Efficacy, Quality, and Multidisciplinary topics. Parallel to the working group meetings, the ICH Management Committee and Assembly convened to discuss new harmonization projects and the ongoing operations of the ICH Association. These activities supported ICH’s mission to promote efficient, resource-conscious drug development and foster collaboration on global regulatory standards.
74. 2024 Animal Feed Regulatory Program Standards Meeting
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Mobile, Alabama
Conference Start Date: 03/19/2024
Conference End Date: 03/21/2024
Total FDA cost of the conference: $36,194.00
Total number of individuals whose expenses were paid by the FDA: 18
Explanation of how conference advanced the mission of FDA:
Attendance at the 2024 Animal Feed Regulatory Program Standards (AFRPS) Meeting advanced the FDA’s mission by fostering collaboration with state and federal regulatory agencies to improve public health and ensure the safety of the U.S. animal food supply. The meeting supported efforts to achieve and maintain full implementation of AFRPS, which establishes risk-based animal food safety programs and promotes compliance with the Preventive Controls for Animal Food (PCAF) regulation. This collaboration helped prevent animal food safety hazards that could cause illness or injury to animals or humans in facilities handling animal food. By participating, FDA attendees contributed to the development and implementation of uniform laws, regulations, and standards that safeguard the health of animals and people, promote consumer protection, and ensure a fair marketplace for the animal food industry. FDA’s role as advisors on AAFCO Committees, including the Training and Education Committee, further reinforced the importance of training and capacity-building for regulatory personnel.
General description of the scientific conference activities:
The 2024 Animal Feed Regulatory Program Standards Meeting, organized by the Association of American Feed Control Officials (AAFCO), provided a critical forum for state, federal, and local regulatory agencies to address key issues concerning the regulation of animal feeds and animal drug remedies. AAFCO, a voluntary association with over 110 years of leadership, facilitates collaboration among regulatory agencies, trade associations, industry representatives, and consumer advocates to ensure the safety and uniformity of animal food programs. The meeting focused on achieving three primary goals: ensuring consumer protection, safeguarding the health of animals and humans, and maintaining a level playing field for the animal food industries. These goals were accomplished through discussions on developing and implementing uniform laws, regulations, standards, definitions, and enforcement policies. Participants also addressed analytical and manufacturing methodologies, enhancing regulatory approaches to animal food safety. The meeting served as a platform for building partnerships, sharing knowledge, and working collectively toward preventing public health hazards associated with animal food. It also enabled regulatory personnel to network, exchange best practices, and collaborate on training initiatives to advance national food safety efforts.
75. Radiological Society of North America Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Chicago, Illinois
Conference Start Date: 11/26/2023
Conference End Date: 11/30/2023
Total FDA cost of the conference: $35,901.00
Total number of individuals whose expenses were paid by the FDA: 16
Explanation of how conference advanced the mission of FDA:
Attendance at the Radiological Society of North America (RSNA) Annual Meeting advanced the FDA’s mission by providing critical insights into the latest developments in medical imaging technology, including software and AI implementation. The conference allowed FDA attendees to interface with doctors, innovators, and industry leaders, enabling a deeper understanding of how novel technologies impact radiology practices. This knowledge strengthened the FDA’s ability to regulate medical imaging devices effectively, ensuring they meet safety and performance standards while being used safely and efficiently in clinical practice. Staying informed on emerging advancements, such as AI integration, was essential for meeting the Agency’s role in protecting public health.
General description of the scientific conference activities:
The Radiological Society of North America (RSNA) Annual Meeting is the largest and most widely attended conference for radiologists and related professionals in the United States. As the premier global radiology forum, the event featured state-of-the-art medical imaging products, scientific advancements, and discussions on topics such as AI, software innovation, and novel technology deployment in medical devices. The conference provided attendees with unparalleled opportunities to observe cutting-edge technology and explore how these innovations are implemented in radiology practice. Presentations and interactions with industry leaders and clinicians offered insights into the evolving field of medical imaging, particularly advancements in AI and its applications. The event served as a platform for learning about ongoing industry activities, fostering a better understanding of the safety and effectiveness of radiological devices within the context of emerging technologies.
76. International Society for Pharmacoeconomics and Outcomes Research Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Atlanta, Georgia
Conference Start Date: 05/05/2024
Conference End Date: 05/08/2024
Total FDA cost of the conference: $35,679.00
Total number of individuals whose expenses were paid by the FDA: 21
Explanation of how conference advanced the mission of FDA:
Attendance at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting advanced the FDA’s mission by providing attendees with access to the latest methodologies, data analytics, and evidence-based approaches that drive transformative changes in health and well-being. The conference explored critical topics such as cost-effectiveness analysis, real-world evidence, AI in HEOR methods, patient-centered research, and health equity—areas that align with FDA’s commitment to innovation and public health. For the Center for Devices and Radiological Health (CDRH), participation in ISPOR was particularly mission-critical, as it supported ongoing work with patient-reported outcome measures (PROMs), a growing and integral component of device clinical trials. Keeping up with developments in PROM science directly aligned with MDUFA commitments and enhanced the team’s ability to evaluate and integrate patient preferences into regulatory decision-making. Additionally, interaction with researchers and the patient preference research community enabled FDA staff to advance their knowledge and better understand emerging trends, ultimately supporting biologics safety and regulatory processes.
General description of the scientific conference activities:
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting provided a platform for interdisciplinary discussions among economists, healthcare professionals, policymakers, and industry leaders. The conference featured significant developments in pricing, reimbursement, health technology assessment, and scientific advancements in cost-effectiveness analysis, real-world evidence, and patient-centered research. Topics also included AI applications in HEOR methods, epidemiology, public health, and health equity. ISPOR was one of the premier conferences for patient-reported outcome measures (PROMs), attracting experts who gathered to discuss advancements in PROM science. The event enabled participants to collaborate, exchange ideas, and maintain proficiency in areas essential to their roles, such as epidemiology, pharmaceutical analysis, and statistical methods. By fostering professional development and interdisciplinary connections, the conference contributed to ongoing efforts to balance affordability, access, and effectiveness in healthcare.
77. Parenteral Drug Association Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Long Beach, California
Conference Start Date: 03/25/2024
Conference End Date: 03/27/2024
Total FDA cost of the conference: $35,180.00
Total number of individuals whose expenses were paid by the FDA: 7
Explanation of how conference advanced the mission of FDA:
Attendance at the Parenteral Drug Association (PDA) Annual Meeting advanced the FDA’s mission by providing attendees with the latest information on traditional and biopharmaceutical science, manufacturing technology, quality standards, and evolving regulations. The conference enabled participants to engage with transformative approaches to the development of ultra-rare genetic diseases and super-orphaned drugs, supporting the FDA’s role in regulating and advancing these critical therapies. Discussions on global regulatory convergence and professional development helped attendees refine their expertise and apply cutting-edge knowledge to regulatory decision-making. This ensured FDA employees remained at the forefront of innovations, improving oversight and public health outcomes.
General description of the scientific conference activities:
The Parenteral Drug Association (PDA) Annual Meeting provided a unique opportunity for professionals to enhance their skills, gain insights into the latest technologies and practices, and explore innovative solutions. The conference featured facilitated roundtable discussions on current hot topics, including professional development and global regulatory convergence, as well as a tour of Dendreon’s advanced cellular therapy manufacturing facility. The opening plenary session highlighted transformative approaches to developing treatments for ultra-rare genetic diseases and super-orphaned drugs. As the premier industry event, the PDA Annual Meeting showcased cutting-edge technologies, innovative ideas, and practical solutions to real-world challenges. Future-focused abstracts and case studies displayed emerging trends and successful strategies, offering attendees actionable information and unique perspectives to address evolving challenges in biopharmaceutical science and manufacturing.
78. Food and Drug Law Institute Tobacco and Nicotine Products Regulation and Policy
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, District of Columbia
Conference Start Date: 10/26/2023
Conference End Date: 10/27/2023
Total FDA cost of the conference: $34,901.00
Total number of individuals whose expenses were paid by the FDA: 14
Explanation of how conference advanced the mission of FDA:
Attendance at the Food and Drug Law Institute (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference advanced the FDA’s mission by providing critical updates on the regulation of tobacco and nicotine products. Attendees heard directly from FDA about the latest developments in regulations, guidance documents, compliance, enforcement, and other initiatives. The conference covered essential topics such as the Deeming Rule, the Public Health Standard, Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product Applications (MRTPs), advertising, marketing, and pending litigation. This knowledge enabled FDA staff, particularly from the Center for Tobacco Products (CTP), to remain informed on emerging regulatory challenges and effectively develop tobacco-related policies that protect public health. Failure to attend would have limited staff's ability to stay current on timely issues and updates from experts across industry, regulatory bodies, and stakeholder sectors.
General description of the scientific conference activities:
The Food and Drug Law Institute (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference brought together a diverse group of stakeholders, including public health advocates, researchers, manufacturers, lawyers, consumer interest groups, entrepreneurs, and government agencies. Over two days, participants engaged in discussions on effectively regulating the broad spectrum of tobacco and nicotine products in the United States. The conference featured interactive dialogues between panelists and the audience, providing a platform to discuss timely issues in tobacco regulation. Attendees explored topics such as the Deeming Rule, Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product Applications (MRTPs), compliance, enforcement, advertising, and marketing practices, as well as recent and pending litigation. The event served as an opportunity for participants to gain a comprehensive understanding of the latest developments in tobacco law, policy, and regulatory practices.
79. International Society for Pharmaceutical Engineering Annual Meeting and Expo
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Las Vegas, Nevada
Conference Start Date: 10/15/2023 Conference End Date: 10/18/2023
Total FDA cost of the conference: $34,421.00
Total number of individuals whose expenses were paid by the FDA: 13
Explanation of how conference advanced the mission of FDA:
Attendance at the 2023 International Society for Pharmaceutical Engineering (ISPE) Annual Meeting & Expo advanced the FDA’s mission by supporting efforts to modernize and harmonize pharmaceutical science and manufacturing. The conference provided critical education on production systems, quality systems, and advanced manufacturing innovations. It enabled FDA attendees to engage with key stakeholders, facilitating effective policy development to accelerate the adoption of advanced technologies in the industry. CDRH presented on CSA principles and its collaboration with the ISPE GAMP community, promoting the CSA framework to align validation expectations for digital technologies in life sciences. FDA led mission-critical program efforts supporting advanced manufacturing and digital transformation in medical devices, while also contributing to a cross-agency working group with CDER to harmonize regulatory approaches. Participation in this conference was essential to advancing FDA’s digital transformation initiatives and promoting consistency across regulatory frameworks.
General description of the scientific conference activities:
The 2023 International Society for Pharmaceutical Engineering (ISPE) Annual Meeting & Expo focused on excellence, modernization, and harmonization in pharmaceutical science and manufacturing on a global scale. The event offered a comprehensive educational program with technical sessions on supply chain operations, facilities, equipment, information systems, product development, quality systems, regulatory guidance, and innovative technologies. The conference attracted pharmaceutical and biopharmaceutical professionals at all levels, including emerging leaders, senior executives, and representatives from global regulatory agencies. The Partner Showcase highlighted the latest technologies and services for the pharmaceutical industry, including advancements in digital transformation, maturity assessments, advanced manufacturing, and alignment between CSA and GAMP principles. The event also featured collaborative discussions on Good Automated Manufacturing Practices (GAMP), which serve as a benchmark for regulated industries. Attendees gained valuable insights into industry advancements and engaged with peers to explore the latest trends and innovations in pharmaceutical manufacturing and regulatory practices.
80. National Institute of Health Tobacco Regulatory Science Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Bethesda, Maryland
Conference Start Date: 10/16/2023
Conference End Date: 10/18/2023
Total FDA cost of the conference: $33,556.00
Total number of individuals whose expenses were paid by the FDA: 94
Explanation of how conference advanced the mission of FDA:
Attendance at the National Institutes of Health (NIH) Tobacco Regulatory Science Program (TRSP) Meeting advanced the FDA’s mission by supporting research aimed at informing the regulation of the manufacture, marketing, and distribution of tobacco products. The meeting facilitated discussions on key research findings in tobacco regulatory science (TRS), including health communication, addiction, health effects, behaviors, and tobacco use among special populations such as youth and young adults. As the Regulatory Sciences Project Manager, attending this conference provided the opportunity to support the NCTR/CTP research portfolio by learning about potential research opportunities, exploring the latest findings from CTP-funded research, and networking with scientists and CTP colleagues. These activities contributed to the FDA’s efforts to protect Americans from tobacco-related disease and death through evidence-based regulations.
General description of the scientific conference activities:
The Tobacco Regulatory Science Program (TRSP) is an interagency partnership between the NIH and FDA’s Center for Tobacco Products (CTP) that fosters research on tobacco regulation. The TRSP meeting included plenary sessions, poster presentations, and symposium discussions, offering attendees insights into the latest developments in tobacco regulatory science. Key topics of focus included health communication, tobacco use among youth and young adults, digital media, novel research methods, and addiction. Researchers had the opportunity to organize 60-75-minute symposium sessions, which featured a chair, optional discussant, and 3-5 speakers exploring specific TRS topics from multiple scientific perspectives. The meeting also served as a platform for researchers and program officials to share accomplishments, discuss progress, and identify new opportunities for collaboration. The meeting highlighted the breadth of CTP-funded research and provided a valuable forum for advancing interdisciplinary discussions critical to the FDA’s regulatory initiatives.
81. American Society of Laser Medicine and Surgery
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Baltimore, Maryland
Conference Start Date: 04/11/2024
Conference End Date: 04/14/2024
Total FDA cost of the conference: $32,891.00
Total number of individuals whose expenses were paid by the FDA: 15
Explanation of how conference advanced the mission of FDA:
Attendance at the American Society of Laser Medicine and Surgery conference advanced the FDA’s mission by equipping CDRH employees with enhanced knowledge of energy-based devices, including medical lasers and surgical devices. This training extended their understanding of current technology, aligning with the agency's commitment to protecting and promoting public health in energy-based medicine and science. Employees gained insights into device safety, industry trends in dermatology and plastic surgery, and key considerations for developing devices from concept to market. These learnings prepared employees for the review of medical device applications and improved their ability to regulate such technologies effectively.
General description of the scientific conference activities:
The American Society of Laser Medicine and Surgery conference offered high-quality, progressive training designed to enhance the development and morale of attendees. The event provided hands-on opportunities to explore energy-based devices regulated by the FDA, while also allowing participants to interact with inventors, manufacturers, and key opinion leaders. The conference featured invited CDRH speakers who discussed critical considerations for device development, from initial concept to market readiness. Presentations covered device safety and industry trends in dermatology and plastic surgery, offering valuable insights into the practical use of energy-based technologies. These activities allowed attendees to gain a deeper understanding of the devices they review and fostered a comprehensive perspective on industry advancements.
82. MedCon Conference
Applicable Conference Type: FDA Hosted/Sponsored/Co-Sponsored
Conference Location: Columbus, Ohio
Conference Start Date: 04/23/2024
Conference End Date: 04/26/2024
Total FDA cost of the conference: $32,861.00
Total number of individuals whose expenses were paid by the FDA: 33
Explanation of how conference advanced the mission of FDA:
Attendance at the MedCon conference advanced the FDA’s mission by fostering collaboration and knowledge exchange between FDA regulators and the medical device industry. The conference provided attendees with critical updates on new requirements, policies, and regulatory issues related to medical devices, enabling FDA staff, including CSOs, to perform more efficient inspections. Presentations by FDA officials outlined CDRH leadership highlights, strategic efforts, and upcoming initiatives for 2024, aligning with the Center’s focus on scientific and efficient product evaluation. The conference also addressed regulatory and compliance challenges faced by the industry, including device supply chain and shortage issues exacerbated by COVID-19. FDA employees, some of whom served as invited speakers, shared updates on CDRH’s activities and perspectives while gathering valuable feedback from stakeholders on policies to improve supply chain resilience. This collaborative outreach was mission-critical to ensure the safe and effective regulation of medical devices and maintain strong industry partnerships.
General description of the scientific conference activities:
The MedCon conference, co-sponsored by the Association of Food and Drug Officials (AFDO), Regulatory Affairs Professionals Society (RAPS), and FDA’s Office of Medical Device and Radiological Health Division 1, was a three-day event designed to address regulatory and compliance challenges in the medical device industry. Established in 2010 as a collaborative effort between FDA and Xavier University, the conference engaged medical device companies of all sizes alongside federal and state regulatory officials. The event featured workshops, quality discussions, and interactive sessions that explored device manufacturing, new regulations, and compliance strategies. Content-rich sessions included uncommon collaboration and deep dialogue between industry representatives and government agencies. Updates on FDA device requirements, policies, and emerging issues provided attendees with actionable insights to enhance regulatory practices. CDRH presented on CDRH’s leadership highlights and upcoming goals, while FDA speakers offered updates on device supply chain challenges and ongoing efforts to improve resilience. The conference served as a critical platform for stakeholders to exchange ideas, discuss solutions, and stay informed about regulatory shifts in the medical device sector.
83. American Society of Tropical Medicine and Hygiene Annual Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Chicago, Illinois
Conference Start Date: 10/18/2023
Conference End Date: 10/22/2023
Total FDA cost of the conference: $32,819.00
Total number of individuals whose expenses were paid by the FDA: 18
Explanation of how conference advanced the mission of FDA:
Attendance at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting advanced the FDA’s mission by keeping OBRR attendees informed about the latest developments in vaccines and diagnostics for parasitic agents that impact blood safety. The meeting provided critical updates in tropical medicine and global health, ensuring FDA regulators are equipped with the most current scientific knowledge to oversee parasitic vaccines and diagnostics effectively. OBRR attendees gained valuable insights from targeted, transdisciplinary sessions and presentations on human-pathogenic bacteria, viruses, and parasites of public health importance. Collaborative group members on Leishmania vaccine development, invited to present their findings published in high-impact journals, contributed to discussions that will inform FDA regulatory practices. This engagement directly supported FDA’s efforts to regulate products based on robust scientific evidence, thereby protecting public health.
General description of the scientific conference activities:
The American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting is a premier international forum for the exchange of scientific and clinical advances in tropical medicine and global health. This five-day educational event, attended by approximately 4,900 professionals from academia, government, non-profits, NGOs, industry, the military, and private practice, included four pre-meeting courses and featured transdisciplinary sessions, a microbiology track, and networking opportunities. The conference targeted a diverse audience of researchers, professors, public health officials, practicing physicians, and healthcare providers working in tropical medicine, hygiene, and global health. Topics ranged from human-pathogenic bacteria, viruses, and parasites to innovative diagnostics and vaccines. Attendees had access to cutting-edge discussions and presentations by world experts, including updates on research findings and disease control strategies. The meeting provided unparalleled learning and networking opportunities, fostering collaboration across sectors to advance global health initiatives.
84. Manufactured Food Regulatory Program Alliance Meeting
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Little Rock, Arkansas
Conference Start Date: 02/26/2024
Conference End Date: 02/29/2024
Total FDA cost of the conference: $32,751.00
Total number of individuals whose expenses were paid by the FDA: 24
Explanation of how conference advanced the mission of FDA:
Attendance at the Manufactured Food Regulatory Program Alliance Meeting advanced the FDA’s mission of protecting public health by supporting the strategic goals outlined in ORA’s Strategic Plan. Specifically, it contributed to Goal 1: fostering a highly capable and adaptable workforce by training and developing employees to address future challenges (Objective 1.2). It also addressed Goal 3: promoting a culture of safety and quality in regulated industries (Objective 3.1), and Goal 4: advancing an integrated public health system by increasing mutual reliance on regulatory and public health partner work, data, and actions (Objective 4.3). By participating, FDA employees engaged with the integrated food safety community and fostered partnerships with local, tribal, state, and federal regulators. This collaboration strengthened mutual reliance and ensured alignment with collective FDA and state regulatory efforts. Failure to attend would have hindered the agency’s ability to meet its strategic goals and maintain critical partnerships essential for advancing food safety.
General description of the scientific conference activities:
The Manufactured Food Regulatory Program Alliance Meeting brought together FDA employees, state regulators, and other stakeholders to promote collaboration within the integrated food safety community. The conference focused on training and workforce development to prepare for future advances and challenges in the regulatory landscape. Participants engaged in discussions and workshops aimed at supporting a culture of safety and quality in regulated industries and fostering partnerships with local, tribal, and federal agencies. The meeting emphasized mutual reliance, shared data, and coordinated actions to enhance public health protections. Travel and in-person attendance were mission-critical to achieving these objectives and maintaining a collective FDA presence within the regulatory community.
85. 60th Annual North American Chemical Residue Workshop
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Fort Lauderdale, Florida
Conference Start Date: 07/14/2024
Conference End Date: 07/17/2024
Total FDA cost of the conference: $32,621.00
Total number of individuals whose expenses were paid by the FDA: 19
Explanation of how conference advanced the mission of FDA:
Attendance at the 60th Annual North American Chemical Residue Workshop (NACRW) advanced the FDA’s mission by equipping attendees with critical knowledge of recent advancements in the analysis of veterinary drugs, pesticides, mycotoxins, and other chemical residues in food and environmental samples. This information directly supports the efforts of CVM and ORA in safeguarding public health through improved analytical chemistry techniques. Participation facilitated learning about emerging contaminants, new multiresidue methods, and state-of-the-art instrumentation, enhancing staff proficiency and technical knowledge. Discussions during poster and oral sessions provided insights into regulatory issues, quality control and assurance methods, and international programs, all of which are integral to supporting CVM’s mission goals and advancing analytical capabilities for FDA-regulated products. Missing the event would have hindered FDA staff's ability to stay current with critical innovations and networking opportunities vital for professional development and public health efforts.
General description of the scientific conference activities:
The 60th Annual North American Chemical Residue Workshop (NACRW), sponsored by FLAG Works, Inc., brought together approximately 300–350 scientists from government, academia, and industry to discuss trace-level analyses of pesticides, veterinary drug residues, and other chemical contaminants in food, animal feed, and environmental samples. The workshop featured a comprehensive program designed for bench chemists, technical scientists, laboratory managers, and quality managers. Sessions included targeted multiresidue methods, sample preparation techniques, mass spectrometric methods, and discussions on emerging contaminants, non-targeted analysis, and validation practices. The event provided training, facilitated the development and distribution of new analytical methods, and created opportunities for networking and professional collaboration. Attendees explored regulatory issues affecting chemical residue work, viewed vendor exhibits showcasing advanced instrumentation, and gained valuable insights into residue analysis methodologies. These activities fostered skill development, knowledge exchange, and innovation within the scientific community.
86. 55th Annual Meeting of the Environmental Mutagenesis and Genomics Society
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Palm Springs, California
Conference Start Date: 09/07/2024
Conference End Date: 09/11/2024
Total FDA cost of the conference: $32,480.00
Total number of individuals whose expenses were paid by the FDA: 16
Explanation of how conference advanced the mission of FDA:
Attendance at the 55th Annual Meeting of the Environmental Mutagenesis and Genomics Society (EMGS) advanced the FDA’s mission by equipping participants with knowledge on how environmental exposures impact genomic integrity and human health. The conference addressed critical topics such as DNA repair, mutation mechanisms, and the influence of environmental toxins, including tobacco smoke and aerosols, on genomic, proteomic, and metabolic signatures. This knowledge base is vital for developing biomarkers and improving regulatory policies to mitigate the risks of environmental exposures on public health. By participating, FDA attendees contributed to sound, science-driven decisions that support the agency’s efforts to protect people from environmental hazards while fostering innovation in regulatory science.
General description of the scientific conference activities:
The 55th Annual Meeting of the Environmental Mutagenesis and Genomics Society (EMGS) provided a forum for exploring the impacts of environmental toxins and toxicants on human physiology and biochemistry, with a focus on their effects on DNA, RNA, proteins, and metabolites. The conference included symposia, platform and poster sessions, pre-conference workshops, and presentations by internationally recognized speakers. Sessions highlighted cutting-edge research and technologies in basic, applied, and regulatory science, emphasizing the development and application of transgenic technology and methods for studying mutations and DNA repair. The meeting also promoted professional development and collaboration through both formal and informal activities, fostering the next generation of scientists. Key discussions included how environmental agents affect genomic and metabolic signatures and how this knowledge can inform biomarker development and regulatory policies aimed at addressing human health concerns.
87. Endocrine Society Annual Conference
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Boston, Massachusetts
Conference Start Date: 06/01/2024
Conference End Date: 06/04/2024
Total FDA cost of the conference: $31,439.00
Total number of individuals whose expenses were paid by the FDA: 10
Explanation of how conference advanced the mission of FDA:
Attendance at the Endocrine Society Annual Conference advanced the FDA’s mission by equipping attendees with the latest knowledge in endocrinology, supporting the review and regulation of products related to cell and gene advanced therapies. The conference provided critical updates on scientific and clinical guidelines, standards of care, and technological advancements in endocrinology, including diabetes, enabling FDA reviewers and regulators to remain current in their fields. This knowledge directly supported the regulatory and review work within OTP and the Division of Chemistry and Technological Devices by enhancing the understanding of endocrine diseases and their implications for medical device development. Attendees gained insights into cutting-edge advancements and research findings, which informed pre- and post-market reviews of devices for diagnosing and managing endocrine-related conditions, ultimately aligning with the FDA’s mission to protect human health.
General description of the scientific conference activities:
The Endocrine Society Annual Conference, ENDO 2024, served as the signature meeting in endocrinology, bringing together world-renowned speakers, leading experts, researchers, and respected clinicians. The event showcased the latest advances in research, clinical care, and the social implications of endocrinology. Presentations covered a broad spectrum of topics, including cardiovascular endocrinology, endocrine disruption, and pediatric endocrinology. The conference offered attendees opportunities to connect with thousands of healthcare practitioners and scientists, exchanging knowledge on the most recent findings, current trends, and innovations in hormone science and clinical care. Sessions included advice on patient care, discussions on new research advancements, and updates on guidelines and standards of care. This collaborative environment allowed attendees to refresh their clinical knowledge, engage with peers, and explore innovations to advance hormone health and science.
88. Association for the Advancement of Medical Instrumentation Medical Device Standards
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Washington, District of Columbia
Conference Start Date: 02/20/2024
Conference End Date: 02/22/2024
Total FDA cost of the conference: $31,258.00
Total number of individuals whose expenses were paid by the FDA: 22
Explanation of how conference advanced the mission of FDA:
Attendance at the Association for the Advancement of Medical Instrumentation (AAMI) Medical Device Standards conference advanced the FDA’s mission by providing critical updates on medical device standards development and stakeholder engagement. The conference, co-sponsored by FDA, included discussions on current and future standard activities, with a focus on medical device sterility standards and efforts to reduce sterilant emissions from device sterilization processes. FDA/CDRH attendees gained insights into the draft standards for radiation sterilization, an important alternative to ethylene oxide sterilization, supporting the agency’s initiative to mitigate harmful emissions. Real-world evidence and case studies presented during the workshop informed regulatory practices, enhancing the ability to oversee device safety and sterility effectively. This knowledge is vital for driving improvements in medical device regulation and aligning with public health goals.
General description of the scientific conference activities:
The AAMI Medical Device Standards conference is an international event co-sponsored by FDA, focusing on the development and implementation of medical device standards. The event included workshops and sessions dedicated to sterility standards, sterilant emission reduction, and alternative sterilization methods. Attendees received updates on radiation sterilization standards, with practical examples and case studies illustrating the dosimetric aspects and processing workflows. The workshop provided attendees with a comprehensive view of radiation processing as an alternative to ethylene oxide sterilization, showcasing its potential to reduce environmental impact. The conference facilitated stakeholder engagement, fostering collaboration among industry, regulatory bodies, and standards organizations. This annual meeting served as a critical platform for advancing medical device standards, promoting innovation, and supporting global harmonization efforts.
89. Society for Epidemiological Research
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Austin, Texas
Conference Start Date: 06/18/2024
Conference End Date: 06/22/2024
Total FDA cost of the conference: $30,357.00
Total number of individuals whose expenses were paid by the FDA: 13
Explanation of how conference advanced the mission of FDA:
Attendance at the Society for Epidemiologic Research (SER) Annual Meeting advanced the FDA’s mission by supporting scientific collaboration, advancing evidence synthesis, and enhancing the regulatory review process. The conference provided critical updates on epidemiologic research, methodologies, and surveillance techniques, equipping attendees with the tools to critically analyze research findings and inform regulatory activities. For the Center for Tobacco Products (CTP), participation facilitated recruitment efforts to fill STEM positions critical to advancing strategic priorities, including product review, regulation writing, public education, compliance, and enforcement efforts. Additionally, attendees from the PATH Branch gained insights to improve data analysis, develop research reports, and contribute to the tobacco regulatory science evidence base. These activities directly supported FDA’s goal of promoting public health by using robust epidemiological findings to inform regulatory decisions.
General description of the scientific conference activities:
The Society for Epidemiologic Research (SER) Annual Meeting brought together over 1,000 professionals from research, education, and healthcare to explore developments in epidemiology. The event featured the John C. Cassel Memorial Lecture, Tyroler Student Prize Paper presentations, contributed papers, symposia, and posters addressing a wide range of epidemiological issues. The meeting offered advanced training opportunities on cutting-edge topics in epidemiologic research and surveillance while fostering collaboration among a diverse group of professionals. Attendees participated in discussions on research methodologies, shared experiences, and engaged with potential collaborators and employers. The conference also facilitated targeted recruitment efforts, enabling CTP’s Outreach and Special Programs Team (OSPT) to connect with qualified candidates to support critical FDA initiatives. These activities enhanced the exchange of knowledge and expertise, strengthening the field of epidemiology and its application to regulatory science.
90. National Environmental Health Association Annual Educational Conference and Exhibition
Applicable Conference Type: Non-FDA Conference Attended by FDA
Conference Location: Pittsburgh, Pennsylvania
Conference Start Date: 07/15/2024
Conference End Date: 07/18/2024
Total FDA cost of the conference: $30,237.00
Total number of individuals whose expenses were paid by the FDA: 13
Explanation of how conference advanced the mission of FDA:
Attendance at the National Environmental Health Association (NEHA) Annual Educational Conference & Exhibition advanced the FDA’s mission by promoting communication and collaboration across all levels of government, industry, and academia, aligning with the goals of the Food Safety and Modernization Act (FSMA). The event provided critical food safety training in retail and manufactured foods, with a specific focus on process monitoring, verification activities, and preventive controls for human and animal food. The knowledge gained from the conference supported OTED’s mission by ensuring the maintenance of its course materials and enhancing FDA’s outreach and liaison activities with state and local officials. By engaging in discussions on the Integrated Food Safety System (IFSS), FDA Model Food Code, and other regulatory standards, attendees strengthened cooperation and resource leveraging essential to advancing food safety initiatives and protecting public health.
General description of the scientific conference activities:
The National Environmental Health Association (NEHA) Annual Educational Conference & Exhibition offered a comprehensive agenda featuring presentations, learning labs, and specialized training sessions. Topics included the Integrated Food Safety System (IFSS), Regulatory and Laboratory Training System (RLTS), FDA Model Food Code, National Retail Food Regulatory Program Standards, self-assessments, verification audits, risk factor studies, and foodborne disease prevention. Attendees received targeted training in retail and manufactured food safety, focusing on process monitoring, verification activities, and the implementation of preventive controls for human and animal food. These educational sessions provided valuable resources for regulators and public health professionals, fostering collaboration between federal, state, and local officials. The event served as a platform for sharing best practices, advancing food safety knowledge, and strengthening the partnerships necessary to implement FSMA effectively.