アジェンダ
1:00 PM — 4:30 PM
Course: Combination Product Advanced Case Studies7:00 AM — 8:15 AM
7:00 AM — 4:45 PM
8:15 AM — 8:30 AM
Welcome and Opening Remarks8:30 AM — 9:00 AM
Keynote Address9:00 AM — 10:00 AM
Session 1: FDA News Feed: 201710:00 AM — 10:30 AM
10:30 AM — 11:30 AM
Session 2: 21st Century Cures and PDUFA: Combination Products Implications11:30 AM — 1:15 PM
1:15 PM — 2:15 PM
Session 3: Appropriate GMPs for Combination Products3:15 PM — 3:45 PM
3:45 PM — 4:45 PM
Session 5: Generics for Combination Products: It’s Complicated4:45 PM — 6:00 PM
7:00 AM — 8:15 AM
7:00 AM — 3:15 PM
8:15 AM — 8:30 AM
Opening Remarks9:00 AM — 10:30 AM
Session 6: Navigating Global Combination Product Regulations10:30 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 7: Digital Health Combination Products: What’s Next?12:30 PM — 2:00 PM
2:00 PM — 3:30 PM
The View from the Top: FDA Panel