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Hyatt Regency Bethesda

Sep 28, 2015 7:30 AM - Sep 29, 2015 4:30 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development

Engage with key regulators and partners in practical approaches to navigate regulatory requirements, enhance collaboration and accelerate combination product development.

Agenda

Day 1 Sep 28, 2015

7:30 AM — 8:30 AM

Registration & Continental Breakfast

8:30 AM — 9:00 AM

Welcome & Opening Remarks

9:00 AM — 10:30 AM

Session 1: FDA Update on Combination Products

10:30 AM — 11:00 AM

Refreshment Break

11:00 AM — 12:30 PM

Session 2: CGMP Guidance - Part One

12:30 PM — 1:45 PM

Luncheon

1:45 PM — 3:15 PM

Session 3: CGMP Guidance - Part Two - A Panel Discussion

3:15 PM — 3:45 PM

Refreshment Break

3:45 PM — 5:15 PM

Session 4: Collaboration in the Industry

5:15 PM — 6:15 PM

Networking Reception

Day 2 Sep 29, 2015

7:30 AM — 8:30 AM

Registration and Continental Breakfast

8:30 AM — 10:00 AM

Session 5: Human Factors and Other Common Device Deficiencies

10:00 AM — 10:30 AM

Refreshment Break

10:30 AM — 12:00 PM

Session 6: Global Updates

12:00 PM — 1:00 PM

Luncheon

1:00 PM — 2:30 PM

Session 7: Roundtable Discussions

2:30 PM — 3:00 PM

Refreshment Break

3:00 PM — 4:30 PM

Session 8: Ask the Regulators

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Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development

Agenda

Be informed and stay engaged.