Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2024 Session 1 - The Medical Product Development Enterprise: Past, Present, and Future Perspectives
Date:
Wednesday, January 17, 2024 - 8:00 am to Friday, January 19, 2024 - 4:00 pm
Location:
University of California Washington Center (UCDC), 1st floor meeting room
1608 Rhode Island Ave NW, Washington DC
This is Session 1 of 6. Must register for the entire 2024 Course and not per session.
Session Co-chairpersons:
Charlie T. Gombar, PhD, ACDRS Director
Daniela Drago, PhD RAC FRAPS FTOPRA, Expert Consultant, NDA Partners
Topics
(subject to change)
- History of the pharmaceutical enterprise
- Development timelines
- Principles of contemporary drug development and regulatory science
- Patient perspectives in medical product development
- Pharmacoeconomics, health technology assessment, and methods for comparison of economic value for different products
- Global health trends, disease management, and their effect on health outcomes
- Regulatory pathways for drugs and biologics
- Regulatory landscape and development challenges in pediatric, cell and gene therapies, and novel treatment modalities
- Decision points in development of small and large molecules
- Management science: Portfolio, projects, and teams
- Target product profile: A key strategic tool in product development
- Special topics based on cutting edge science, changing regulations, controversies, etc.