Agenda
2:00 PM — 2:30 PM
On the Soapbox: Right to Try3:00 PM — 4:00 PM
FDA Expectations for Demonstration of Interchangeability3:00 PM — 4:15 PM
TFDA Town Hall8:00 AM — 9:15 AM
Artificial Intelligence: The Future of Regulatory Affairs8:00 AM — 9:15 AM
Global Regulatory Strategies for Biosimilars8:00 AM — 9:15 AM
Update on Collaboration and Trends in Global Companion Diagnostics10:30 AM — 11:30 AM
Expanded Access: Where Are We Now?10:30 AM — 11:45 AM
Generic Drug Town Hall2:00 PM — 3:15 PM
Navigating the Regulatory Landscape of Drug-Device Combination Products4:15 PM — 5:30 PM
Electronic Submissions Demystified4:15 PM — 5:15 PM
Is It Time to Change the Content and Format of Labeling?4:15 PM — 5:30 PM
Priority Review Vouchers: Here to Stay and Worth the Effort?8:00 AM — 9:15 AM
Global Rare Disease Town Hall10:30 AM — 11:45 AM
Harmonization Beyond ICH10:30 AM — 11:45 AM
New FDA Draft Guidance on Part 11 in Clinical Investigations10:30 AM — 11:45 AM
Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How2:00 PM — 3:00 PM
AdPromo: Assessing Risk in the Current Regulatory Environment2:00 PM — 3:15 PM
PMDA Town Hall2:00 PM — 3:15 PM
What's New in Health Canada: Updates and New Endeavors4:00 PM — 5:00 PM
Update on BREXITHave an account?