アジェンダ
12:30 PM — 5:00 PM
1:30 PM — 5:00 PM
Short Course: How the MDR will Affect Combination Products7:30 AM — 8:15 AM
7:30 AM — 5:30 PM
8:15 AM — 8:30 AM
Welcome and Opening Remarks8:30 AM — 9:00 AM
Keynote Address9:00 AM — 9:45 AM
Session 1: FDA Update9:45 AM — 10:15 AM
11:45 AM — 1:15 PM
1:15 PM — 2:00 PM
Session 3: Combination Products Lifecycle Management Issues Today2:45 PM — 3:15 PM
3:15 PM — 4:00 PM
Session 5: Innovator's Perspective4:45 PM — 5:45 PM
7:15 AM — 8:15 AM
7:30 AM — 4:45 PM
8:15 AM — 8:30 AM
Welcome to Day 28:30 AM — 9:00 AM
Day 2 Keynote Address9:00 AM — 10:30 AM
FDA Panel10:30 AM — 11:00 AM
11:00 AM — 11:45 AM
Session 7: Global Regulatory Changes and Emerging Markets11:45 AM — 1:15 PM
1:15 PM — 2:45 PM
Session 8: Connected Combination Products2:45 PM — 3:15 PM
3:15 PM — 4:00 PM
Session 9: Devices Referencing Drugs: Post-Market Considerations4:00 PM — 4:45 PM
Session 10: Aligning Drug- and Device-led Combination Product Policy4:45 PM — 4:45 PM
Closing Remarks