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Radisson Grand Place

Jan 27, 2025 9:00 AM - Jan 29, 2025 6:30 PM

47 Rue du Fossé aix Loups, Brussels, Belgium

2025 Combination Products Summit (presented by DIA and RAPS)

Overview

After a highly successful inaugural event in 2024, DIA and RAPS will reconvene the jointly produced summit, Combination Products in the EU on 28-29 January 2025 at the Radisson Grand Place in Brussels, Belgium. This highly-interactive event will unite key stakeholders across the field - including representatives from EMA, the European Commission, Notified Bodies, National Competent Authorities and Industry - to explore a coordinated drug and device approach to incentivese competitve innovation in Europe.

 

With a distinct focus on addressing challenges and creating efficiencies, the 2025 summit on Combination Products in the EU offers delegates the opportunity to engage with experts and echange ideas via action-oriented working gropus that stimulate ideation and innovation to drive solutions for pragmatic implementation.

 

New this year, the event will also feature a preconference workshop on 27 January focued on 'Introduction to Combination Productis in the EU: Regulatory and Practical Insights'.

 

Who should attend?

This highly-interactive summit will unite key stakeholders across the field - including representatives from EMA, the European Commission, Notified Bodies, National RegulatoryAuthorities and Industry - to explore a coordinated drug and device approach for bringing innovation back to Europe.

 

Learning objectives

  • At the conclusion of this activity, participants should be able to:

    • Explore MDR implementation updates.
    • Discuss the impact of the EU IVDR (challenges, opportunities, lessons learned).
    • Review the current landscape for Companion Diagnostics in the EU.
    • Share insights and case studies about critical combination products issues like MDR article 117/MDR Rule 14, combine clinical trials, AI in medical devices and diagnostics and lifecycle management.
    • Brainstorm ways to encourage innovation and progress in the regulation of conbination products in the EU.

      • Audience Learning Level

       

      Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

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