U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. News & Events
  3. OTP Events, Meetings, and Workshops
  1. News & Events

OTP Events, Meetings, and Workshops

Register for Upcoming Events

The Office of Therapeutic Products (OTP) hosts a variety of events to share information about OTP-regulated products and bring together important stakeholders to discuss the development and advancement of these products. Learn more about our various event series, register for our upcoming events, or find information about previous events.

Learn More About Our Events

RegenMedEd Series

The RegenMedEd series brings together important stakeholders and FDA staff to discuss foundational information about regenerative medicine therapies, such as gene and cell therapy products, and explore opportunities for patients, caregivers, and advocates to engage with FDA to help advance product development. Recent topics include gene therapy clinical trials, the importance of natural history studies, and regenerative medicine 101.

OTP Virtual Town Hall Series

The OTP Virtual Town Halls aim to engage with product development stakeholders and researchers. These town halls have a question-and-answer format with the goal of providing regulatory information to stakeholders to help advance development of OTP-regulated products.

Additional Workshops, Meetings, and Events

In addition to our event series, OTP also hosts a number of other meetings and workshops throughout the year. Most of these events are held virtually and are free and open to the public.

Past Events

Looking for information about previous events? Use the chart below to find more information about our past events, as well as recordings and other event materials.

DateTitleSeries
12/12/24OTP Town Hall: Best Practices for Regulatory Interactions with OTPOTP Virtual Town Hall
12/04/24CBER Listening Meeting on Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases (Hosted by CBER)N/A
11/19/24Workshop on Integration Site Analysis During Long Term Follow-Up for Gene Therapies with Integrating Viral VectorsOTP Workshop
10/30/24Finding Your Support Team While Participating in a Clinical TrialRegenMedEd
09/20/24CBER Listening Meeting on Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases (Hosted by CBER)N/A
09/05/24OTP Virtual Town Hall on Cell Therapy CMC Readiness for Late-Stage INDsOTP Virtual Town Hall
09/04/24Regulatory Do’s and Don’ts: Tips from FDA (Hosted by CDER)N/A
06/04/24OTP Town Hall: CMC Readiness for Gene Therapy BLAsOTP Virtual Town Hall
03/07/24FDA CBER Webinar: Considerations for the Development of CAR T Cell ProductsOTP Guidance Webinar
02/29/24FDA CBER Webinar: Human Gene Therapy Products Incorporating Human Genome EditingOTP Guidance Webinar
10/05/23Warrior Families: Advancing Regenerative Medicine Through ScienceRegenMedEd
08/30/23OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy ProductsOTP Virtual Town Hall
06/08/23OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023OTP Virtual Town Hall
04/27/23Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy ProductsOTP Workshop
04/25/23OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023OTP Virtual Town Hall
04/13/23Clinical Trials: The Patient ExperienceRegenMedEd
03/30/23Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public WorkshopOTP Workshop
03/14/23FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) WorkshopOTP Workshop
02/07/23OTAT Town Hall: Clinical Development of Gene Therapy Products for Rare DiseasesOTP Virtual Town Hall
12/16/22Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy ProductsOTP Workshop
12/07/22OTAT Town Hall: Cell Therapy Chemistry, Manufacturing, and ControlsOTP Virtual Town Hall
11/17/22Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine ProductsOTP Workshop
11/15/22FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy ProductsOTP Workshop
10/27/22Natural History Studies to Support Regenerative Medicine: A How-To WebinarRegenMedEd
09/29/22OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and ControlsOTP Virtual Town Hall
05/24/22Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient AdvocatesRegenMedEd
03/09/22RegenMedEd Webinar: The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare DiseasesRegenMedEd
11/16/21Regenerative Medicine 101 Webinar: Information for Patients, Caregivers & AdvocatesRegenMedEd
05/06/21Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient AdvocatesRegenMedEd
   

Related Resources

OTP Learn

Stay Connected

Sign up for the CBER listserv or follow us on social media to stay up to date on all FDA CBER news and events.

 



Back to Top