Agenda
7:30 AM — 5:30 PM
8:30 AM — 12:00 PM
Course 1: Artificial Intelligence, Machine Learning, and Precision Medicine8:30 AM — 12:00 PM
Course 2: Causal Inference: Weighting Methods and Case Studies1:00 PM — 1:30 PM
Welcome and Opening Remarks1:30 PM — 2:30 PM
Keynote Address2:30 PM — 3:45 PM
Session 1: PDUFA VI Pilot Programs: Overview and Expectation3:45 PM — 4:05 PM
4:05 PM — 5:35 PM
Session 2: Complex Innovative Designs5:35 PM — 6:35 PM
7:30 AM — 8:30 AM
7:30 AM — 5:30 PM
8:30 AM — 8:35 AM
Welcome and Opening Remarks10:05 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 4: Bridging the Gap: RWE and RCT12:00 PM — 1:30 PM
3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 6: Identical Cousins: Generics and Biosimilars5:00 PM — 6:00 PM
7:30 AM — 8:30 AM
7:30 AM — 5:00 PM
8:30 AM — 8:35 AM
8:35 AM — 10:05 AM
Session 7: The Future is Now10:05 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 8: Risk-Based Monitoring12:00 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 9: ICH Guidances from a Global and Regional Perspective3:00 PM — 4:15 PM
Session 10: Senior Leaders (FDA and Industry) Town Hall4:15 PM — 4:15 PM
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