Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2022 Session 1 - The Medical Product Development Enterprise: Past, Present, and Future Perspectives
Monday, January 24, 2022 - 10:00 am to Friday, January 28, 2022 - 3:00 pm
This is Session 1 of 6. Must register for the entire course and not per session.
- 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
- Special topics based on cutting edge science, changing regulations, controversies, etc.
- 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