Agenda
11:00 AM — 12:00 PM
International Regulatory Convergence2:15 PM — 3:15 PM
Communications with Regulators Beyond Formal Meetings2:15 PM — 3:15 PM
Hype Versus Reality: Artificial Intelligence and Drug Development2:15 PM — 3:15 PM
TFDA Town Hall: Focus on Regenerative Medicine2:15 PM — 3:15 PM
Update from Health Canada: The Health Protection Branch3:30 PM — 4:30 PM
Drug Development Tools in a Digital Era3:30 PM — 4:30 PM
Updates on China Regulatory Reform10:30 AM — 11:30 AM
PMDA Town Hall10:30 AM — 11:30 AM
The Future of Combination Products in the EU2:00 PM — 3:15 PM
Driving Complex Generics to Approval: What are the Keys to Success4:15 PM — 5:30 PM
Prescription Drug Labeling: New Guidances from the US FDA10:30 AM — 11:30 AM
Digital Technology Advances Labeling Management and Patient Access10:30 AM — 11:30 AM
Hot Topics in Quality and Regulatory Affairs for Combination Products10:30 AM — 11:30 AM
The Evolving Gene Therapy Regulatory Framework: A Brave New World10:30 AM — 11:30 AM
When is Real World Evidence Ready for Prime Time?2:00 PM — 3:15 PM
Global Rare Disease Town Hall2:00 PM — 3:15 PM
User-Fee Programs Myth Busting: General Financial Principles ExplainedHave an account?