Agenda
12:00 PM — 1:00 PM
FDA Oncology Center of Excellence Pilot Programs: Past, Present, and Future12:00 PM — 1:00 PM
Gene Therapy: Getting Back on Track After COVID-1912:00 PM — 1:00 PM
Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA12:00 PM — 1:00 PM
PMDA Town Hall12:00 PM — 1:00 PM
Asian Town Hall10:00 AM — 11:00 AM
Advancing Medicines’ Regulation in Europe: Key Strategies to 202510:00 AM — 11:00 AM
Office of Generic Drugs and Office of Pharmaceutical Quality Generics Town Hall4:00 PM — 5:00 PM
Frameworks for Digital Endpoints via the IND Pathway2:00 PM — 3:00 PM
Scientific Advances in Biosimilar Development4:00 PM — 5:00 PM
COVID-19 Vaccines: Regulatory Strategies for Public Health Emergencies10:00 AM — 11:00 AM
Using Cloud-Based Platforms to Transform Global Regulatory Data Exchange11:30 AM — 12:30 PM
Real-World Evidence: A Global Regulatory Perspective and DiscussionHave an account?