Agenda

Day 1 Oct 10, 2018

12:30 PM — 5:00 PM

Short Course Registration

1:30 PM — 5:00 PM

Short Course: How the MDR will Affect Combination Products

Day 2 Oct 11, 2018

7:30 AM — 8:15 AM

Continental Breakfast and Networking

7:30 AM — 5:30 PM

Registration

8:15 AM — 8:30 AM

Welcome and Opening Remarks

8:30 AM — 9:00 AM

Keynote Address

9:00 AM — 9:45 AM

Session 1: FDA Update

9:45 AM — 10:15 AM

Refreshment and Networking Break

10:15 AM — 11:45 AM

Session 2: Complex Generic Combination Products – Regulatory Policy Considerations

11:45 AM — 1:15 PM

Luncheon and Networking

1:15 PM — 2:00 PM

Session 3: Combination Products Lifecycle Management Issues Today

2:00 PM — 2:45 PM

Session 4: Combination Product Regulatory Submissions: Considerations for Product Development

2:45 PM — 3:15 PM

Refreshment and Networking Break

3:15 PM — 4:00 PM

Session 5: Innovator's Perspective

4:00 PM — 4:45 PM

Session 6: Requests, Disputes, and Appeals: A Process Primer for Combination Product Applicants

4:45 PM — 5:45 PM

Networking Reception

Day 3 Oct 12, 2018

7:15 AM — 8:15 AM

Continental Breakfast and Networking

7:30 AM — 4:45 PM

Registration

8:15 AM — 8:30 AM

Welcome to Day 2

8:30 AM — 9:00 AM

Day 2 Keynote Address

9:00 AM — 10:30 AM

FDA Panel

10:30 AM — 11:00 AM

Refreshment and Networking Break

11:00 AM — 11:45 AM

Session 7: Global Regulatory Changes and Emerging Markets

11:45 AM — 1:15 PM

Luncheon and Networking

1:15 PM — 2:45 PM

Session 8: Connected Combination Products

2:45 PM — 3:15 PM

Refreshment and Networking Break

3:15 PM — 4:00 PM

Session 9: Devices Referencing Drugs: Post-Market Considerations

4:00 PM — 4:45 PM

Session 10: Aligning Drug- and Device-led Combination Product Policy

4:45 PM — 4:45 PM

Closing Remarks

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Combination Products Conference

Agenda

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