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Bethesda North Marriott Hotel and Conference Center

Oct 29, 2019 7:15 AM - Oct 30, 2019 4:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Combination Products Conference

Where regulators and industry share insights on leveraging regulatory and technological change to advance combination products.

Agenda

Day 1 Oct 28, 2019

12:30 PM — 5:00 PM

Short Course Registration

1:30 PM — 5:00 PM

Short Course: How Much is Enough? Best Practices and Principles for the Non-Lead Constituent Part Within a Regulatory Submission for a Combination Product

Day 2 Oct 29, 2019

7:15 AM — 8:15 AM

Continental Breakfast and Networking

7:15 AM — 4:15 PM

Registration

8:15 AM — 8:30 AM

Welcome and Opening Remarks

8:30 AM — 9:00 AM

Session 1: Keynote Address: Update from the Office of Combination Products

9:00 AM — 10:00 AM

Session 2: Update on Combination Products Policy Development

10:00 AM — 10:30 AM

Refreshment and Networking Break

10:30 AM — 11:45 AM

Session 3: Linking Pharmaceutical Development to the Design Control Process

11:45 AM — 12:30 PM

Luncheon and Networking

12:30 PM — 1:30 PM

Session 4: Cutting Edge–Artificial Intelligence and 3D Printing Revolutionizing Materials, Design, and Manufacturing

1:30 PM — 2:15 PM

Session 5: NB Update: EU MDR Article 117 Current Impact to Drug Delivery Devices

2:15 PM — 2:45 PM

Refreshment and Networking Break

2:45 PM — 3:30 PM

Session 6: The Future of Generic Combination Products

3:30 PM — 4:15 PM

Session 7: Regenerative Medicine and ATMPs: Combined Product Perspectives and Watch-Outs

4:15 PM — 5:15 PM

Networking Reception

Day 3 Oct 30, 2019

7:15 AM — 8:15 AM

Continental Breakfast and Networking

7:15 AM — 4:00 PM

Registration

8:15 AM — 8:30 AM

Day Two Welcome

8:30 AM — 10:00 AM

Session 8: FDA Panel

10:00 AM — 10:30 AM

Refreshment and Networking Break

10:30 AM — 11:30 AM

Session 9: Digital Health: Challenges and Opportunities for Labeling with Drug Companion Apps

11:30 AM — 12:30 PM

Luncheon and Networking

12:30 PM — 1:30 PM

Session 10: Co-Development of Digitally Connected Combination Products

1:30 PM — 2:30 PM

Session 11: One Application or Two? Different Approach to Different Pathways for Approval Process

2:30 PM — 3:00 PM

Refreshment and Networking Break

3:00 PM — 4:00 PM

Session 12: An Interactive Discussion: Technical and Regulatory Challenges in Combination Product Lifecycle Management

4:00 PM — 4:15 PM

Closing Remarks

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Combination Products Conference

Agenda

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