Agenda

Day 1 Jan 28, 2025

8:30 AM — 9:00 AM

Registration and Welcome Coffee

9:00 AM — 9:20 AM

Introduction and Welcome

9:20 AM — 10:40 AM

Opening Plenary

10:40 AM — 11:10 AM

Coffee Break

11:10 AM — 12:30 PM

Combination Products Under Article 117 of the MDR – Alignment on Strategies for Building an Innovative Regulatory Environment in the EU

12:30 PM — 2:00 PM

Lunch Break

2:00 PM — 3:10 PM

Concurrent Breakout: Legacy CDx

2:00 PM — 3:10 PM

Concurrent Breakout: Variations & Lifecycle Management

3:10 PM — 3:30 PM

Coffee Break

3:30 PM — 4:30 PM

Availability of Devices: Context and Challenges

4:30 PM — 4:50 PM

Coffee Break

4:50 PM — 6:00 PM

Rule 14 & Rule 21

6:00 PM — 6:30 PM

Networking Reception

Day 2 Jan 29, 2025

8:30 AM — 8:50 AM

Welcome Coffee

8:50 AM — 9:00 AM

Welcome Remarks and Introduction

9:00 AM — 10:20 AM

COMBINE Program

10:20 AM — 10:45 AM

Coffee Break

10:45 AM — 12:00 PM

Concurrent Breakout: CDx Performance Studies

10:45 AM — 12:00 PM

Concurrent Breakout: Scientific Advice & Structured Dialogue

12:00 PM — 1:00 PM

Lunch Break

1:00 PM — 2:15 PM

Workshop: AI in Medical Devices and Combination Products

1:00 PM — 2:15 PM

Workshop: Future Legislative Changes to Benefit Regulation of Combination Products in Europe (MDR/IVDR revision & connection to the revised GPL)

2:15 PM — 3:15 PM

Closing Plenary: Focus on the Future of Healthcare

3:15 PM — 3:30 PM

Wrap-Up and Closing

3:30 PM — 3:30 PM

Summit Concludes

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2025 Combination Products Summit (presented by DIA and RAPS)

Agenda

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