アジェンダ
7:00 AM — 8:00 AM
7:00 AM — 5:00 PM
8:00 AM — 8:30 AM
Welcome and Opening Remarks8:30 AM — 9:00 AM
Keynote Address9:00 AM — 10:30 AM
Session 1: PDUFA VI Pilot Program and Discussion10:30 AM — 11:00 AM
11:00 AM — 2:15 PM
Session 2: CID - Master Protocols12:20 PM — 1:15 PM
2:15 PM — 5:05 PM
Session 3: Flexible, Efficient Decision-Making: Complex Adaptive Design3:00 PM — 3:30 PM
5:05 PM — 6:05 PM
7:00 AM — 8:00 AM
8:00 AM — 8:10 AM
Welcome to Day Two8:10 AM — 8:40 AM
Day 2 Keynote8:40 AM — 11:30 AM
Session 4: Bayesian Designs: Continuous Learning and Decision-Making9:30 AM — 10:00 AM
11:30 AM — 12:30 PM
12:30 PM — 3:20 PM
Session 5: Alternative Data Sources and Historical Controls1:50 PM — 2:20 PM
3:20 PM — 4:50 PM
Session 6: Global Regulatory Affairs4:50 PM — 5:15 PM
Closing Remarks