アジェンダ
8:15 AM — 8:30 AM
8:30 AM — 9:15 AM
Welcome, Introduction, and Session 1: Introduction/Overview of FDA9:15 AM — 10:00 AM
Sessions 2, 3, and 410:00 AM — 10:15 AM
10:15 AM — 11:45 AM
Session 5: CMC Requirements for an IND11:45 AM — 12:30 PM
12:30 PM — 2:00 PM
Sessions 6, 7, 8, 9, and 102:00 PM — 2:15 PM
Session 11: Interactive Workshop2:15 PM — 2:30 PM
2:30 PM — 5:15 PM
Sessions 12, 13, 14, 15, and 168:15 AM — 8:30 AM
8:30 AM — 9:00 AM
Session 17: Interactive Workshop9:00 AM — 10:00 AM
Sessions 18, 19, and 2010:00 AM — 10:15 AM
10:15 AM — 10:45 AM
Sessions 21 and 2210:45 AM — 11:45 AM
Session 23: CMC Inspections – The PAI11:45 AM — 12:15 PM
Session 24: FDA Enforcement Actions: Form FDA 483 and Warning Letters12:15 PM — 1:15 PM
1:15 PM — 2:30 PM
Sessions 25 and 262:30 PM — 3:00 PM
Session 27: CMC Considerations in Pediatric Development3:00 PM — 3:15 PM
Session 28: References3:15 PM — 3:30 PM
Questions, Answers, and Learner Assessment