Agenda

Día 1 24 oct 2017

1:00 PM — 4:30 PM

Course: Combination Product Advanced Case Studies

Día 2 25 oct 2017

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

Día 3 26 oct 2017

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

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Combination Products Conference

Agenda

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