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Combination Products Conference

Innovation and New Frontiers

Agenda

7:00 AM — 8:15 AM Continental Breakfast
7:00 AM — 4:45 PM Registration
8:15 AM — 8:30 AM Welcome and Opening Remarks
8:30 AM — 9:00 AM Keynote Address
9:00 AM — 10:00 AM Session 1: FDA News Feed: 2017
10:00 AM — 10:30 AM Refreshments and Networking Break
10:30 AM — 11:30 AM Session 2: 21st Century Cures and PDUFA: Combination Products Implications
11:30 AM — 1:15 PM Luncheon
1:15 PM — 2:15 PM Session 3: Appropriate GMPs for Combination Products
2:15 PM — 3:15 PM Session 4: Words Matter: Labeling Challenges Unique to Combination Products
3:15 PM — 3:45 PM Refreshments and Networking Break
3:45 PM — 4:45 PM Session 5: Generics for Combination Products: It’s Complicated
4:45 PM — 6:00 PM Networking Reception

7:00 AM — 8:15 AM Continental Breakfast
7:00 AM — 3:15 PM Registration
8:15 AM — 8:30 AM Opening Remarks
8:30 AM — 9:00 AM Keynote Address: Combination Product Regulation – A Combination Perspective
9:00 AM — 10:30 AM Session 6: Navigating Global Combination Product Regulations
10:30 AM — 11:00 AM Refreshments and Networking Break
11:00 AM — 12:30 PM Session 7: Digital Health Combination Products: What’s Next?
12:30 PM — 2:00 PM Luncheon
2:00 PM — 3:30 PM The View from the Top: FDA Panel