Professional Development
ORES supports professional development to help the FDA meet the regulatory challenges posed by emerging science and technology.
The Office of Regulatory and Emerging Science (ORES) supports lectures, training courses, and symposia that cover a range of topics to help the FDA meet the regulatory challenges posed by new science and technology developments. In addition to supporting a broad regulatory science program—including professional development components—FDA fosters collaborative activities with scientific institutions, academia, and industry.
Lectures
Foundations for Preclinical Review Lecture Series
Periodic presentations to engage subject matter experts from FDA Centers and offices on issues related to obtaining valid, reliable animal models for human disease. Goals include examining common study pitfalls and supporting consistent guidance development.
ORES Lecture Series
Periodic presentations that bring together the FDA research community to share ideas and knowledge and inspire continued advancement in regulatory science with a particular focus on advancing the development and availability of medical countermeasures to counter chemical, biological, radiological, and nuclear (CBRN) threats and emerging infectious diseases.
Training Courses
Achieving Data Quality and Integrity in Maximum Containment Laboratories (Bethesda, MD)
To help address the challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and the University of Texas Medical Branch, Galveston National Laboratory (UTMB) collaborate to provide a week-long annual training course on how to meet GLP requirements in BSL-4 facilities.
2025 Course Information Coming Soon
Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens (Omaha, NE)
This annual course, hosted by FDA and UTMB, focuses on the preparation and execution of research clinical trials to facilitate the approval of MCMs for high-consequence pathogens.
Symposia
FDA Science Forum
Every two years, FDA hosts the FDA Science Forum, featuring an opportunity for the public to view the unique scientific research and collaborative efforts of FDA’s 11,000 scientists across a wide range of disciplines. Sessions include updates on medical countermeasures, infectious disease, pathogen reduction technologies, novel technologies, product development, manufacturing, and more.
Resources for You:
FDA hosts numerous public meetings and workshops each year.
Contact us: ORES@fda.hhs.gov