Agenda
11:00 AM — 12:30 PM
Update from the CFDA10:30 AM — 11:45 AM
International Collaboration in Times of Public Health Crisis10:30 AM — 11:45 AM
Recent Trends in Asian Regulations for Drug Development: What is Coming Next?10:30 AM — 11:45 AM
Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?10:30 AM — 11:30 AM
Update from CBER: Advancing the Development of Complex Biologic Products2:00 PM — 3:15 PM
Regulatory Challenges with Next Generation Sequencing2:00 PM — 3:15 PM
What’s New in Devices: European Medical Device Regulations and MDUFA IV4:00 PM — 5:15 PM
Brexit: Where Are We Now?4:00 PM — 5:15 PM
PMDA Town Hall10:30 AM — 11:45 AM
Evolution of Novel Registration Endpoints as Diseases Become Chronic2:00 PM — 3:15 PM
Expanded Access and Compassionate Use2:00 PM — 3:15 PM
Global Perspective on ICH: Part 1 of 22:00 PM — 3:15 PM
Understanding the New Common Rule and Its Impact to Industry4:00 PM — 5:00 PM
FDA–Health Canada Regulatory Cooperation Council Town Hall4:00 PM — 5:15 PM
Global Perspective on ICH: Part 2 of 24:00 PM — 5:15 PM
Lessons Learned from the Sarepta Exondys 51 Approval4:00 PM — 5:15 PM
The Reauthorization of GDUFA and Its Impact on Sponsor and RegulatorHave an account?