会议日程
10:00 AM — 2:00 PM
Short Course: Introduction to Statistics in Pharmacovigilance9:00 AM — 4:00 PM
Short Course: Aggregate Safety Assessment Planning (ASAP) Process7:30 AM — 8:30 AM
8:30 AM — 8:40 AM
Welcome & Opening Remarks9:25 AM — 10:10 AM
10:10 AM — 11:25 AM
Session 2: Updates on Policies, Guidances, and Regulations – North America11:25 AM — 12:25 PM
11:40 AM — 12:25 PM
Roundtable Discussions12:25 PM — 1:40 PM
Session 3: Updates on Policies, Guidances, and Regulations – Europe1:40 PM — 2:25 PM
2:25 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 Therapeutics5:00 PM — 6:00 PM
7:00 AM — 8:00 AM
9:15 AM — 10:00 AM
10:00 AM — 11:15 AM
Session 7: Insights on Benefit-Risk Assessment11:20 AM — 12:35 PM
Session 8: Risk Management, Past, Present and Future?12:35 PM — 1:35 PM
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 Safety2:50 PM — 3:20 PM
3:20 PM — 4:35 PM
Session 10: Insights into the Collection of Safety Data in Pregnancy4:35 PM — 7:00 PM
Adapting to Generative AI: Changing PV Landscapes7:30 AM — 8:30 AM
8:30 AM — 9:45 AM
Session 11: Signal Detection and Evaluation9:45 AM — 10:05 AM
10:05 AM — 11:20 AM
Session 12: Implementation of Safety Surveillance Plans Roundtables11:20 AM — 11:40 AM
11:40 AM — 12:55 PM
Session 13: The World is Changing, How do We Adapt?12:55 PM — 1:00 PM
Closing Remarks