Agenda
8:30 AM — 8:40 AM
Welcome & Opening Remarks10:10 AM — 11:25 AM
Session 2: Updates on Policies, Guidances, and Regulations – North America12:25 PM — 1:40 PM
Session 3: Updates on Policies, Guidances, and Regulations – Europe2:25 PM — 3:40 PM
Session 4: Updates on Policies, Guidances, and Regulations – Asia3:45 PM — 5:00 PM
Session 5: Safety Management Considerations for Advanced Therapeutics10:00 AM — 11:15 AM
Session 7: Insights on Benefit-Risk Assessment11:20 AM — 12:35 PM
Session 8: Risk Management, Past, Present and Future?12:45 PM — 1:30 PM
Sponsored Roundtable Discussions1:35 PM — 2:50 PM
Session 9: Use of Real-World Data and Real-World Evidence in Safety3:20 PM — 4:35 PM
Session 10: Insights into the Collection of Safety Data in Pregnancy8:30 AM — 9:45 AM
Session 11: Signal Detection and Evaluation10:05 AM — 11:20 AM
Session 12: Implementation of Safety Surveillance Plans Roundtables11:40 AM — 12:55 PM
Session 13: The World is Changing, How do We Adapt?¿Tiene una cuenta?