Agenda

Day 1 Oct 24, 2016

1:30 PM — 5:00 PM

Course: Digital Health Technologies for Combination Products and Beyond: Development and Regulation

Day 2 Oct 25, 2016

7:15 AM — 8:15 AM

Registration and Continental Breakfast

8:15 AM — 8:30 AM

Welcome and Opening Remarks

8:30 AM — 9:00 AM

Keynote Address: Innovation in Medical Product Development: A Regulatory Perspective

9:00 AM — 10:30 AM

Session 1: US and EU Combination Products Regulatory Updates

10:30 AM — 11:00 AM

Refreshment and Networking Break

11:00 AM — 12:30 PM

Session 2: FDA Combination Product Review Process Improvements and Organizational Changes

12:30 PM — 2:00 PM

Luncheon

2:00 PM — 3:30 PM

Session 3: FDA Oncology Center of Excellence: Implications for Intercenter Coordination

3:30 PM — 4:00 PM

Refreshment and Networking Break

4:00 PM — 5:30 PM

Session 4: Combination Products on Capitol Hill

Day 3 Oct 26, 2016

7:30 AM — 8:30 AM

Registration and Continental Breakfast

8:30 AM — 9:00 AM

Keynote Address: Innovation in Medical Product Development: An Industry Perspective

9:00 AM — 10:30 AM

Session 5: Challenges and Opportunities of Differing Regulatory Paradigms for Drugs and Devices

10:30 AM — 11:00 AM

Refreshment and Networking Break

11:00 AM — 12:30 PM

Session 6: Digital Health Technologies: Are They Combination Products? Does It Matter?

12:30 PM — 2:00 PM

Luncheon

2:00 PM — 3:30 PM

Session 7: The Future of the Intercenter Collaboration at FDA

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Combination Products 2016