In-house Educational Training Programs

New Topics for 2006

1. FDA Initiatives and their Impact on CMC Drug Development
This session will cover the FDA Initiatives for the 21st Century, illustrating the concepts of "design space", "pharmaceutical development" "quality by design", ICH Q8, Q9 ("risk management") and Q10. Then, we will outline smart CMC development practices that use these concepts. Suggested scientific studies will be used as examples of appropriate risk management practices.

2. Exploratory INDs

3. New FDA Draft Guidance - GMPs for phase 1 clinical trials