Agenda
8:30 AM — 10:00 AM
Implementation of Quality by Design: Progress Update8:00 AM — 9:30 AM
CMC Development of Breakthrough Therapies10:30 AM — 12:00 PM
Manufacturing Challenges for Breakthrough Products1:30 PM — 3:00 PM
Introducing CDER's Office of Pharmaceutical Quality8:00 AM — 9:30 AM
Balancing Manufacturing Quality Improvements and Drug Shortage8:00 AM — 9:30 AM
ICH Update: Emerging Guidelines10:30 AM — 12:00 PM
Update from the FDA-EMA Parallel Assessment Pilot3:30 PM — 5:00 PM
CMC Regulatory Pathways in the Emerging Markets: Focus on Asia PacificHave an account?