Talk Medical Devices & Combination Products track
S0601 - Innovative EU Regulations - The Future of Combination Products
Wed, Mar 19, 2025 · 8:30–9:40 AM CET Boston 1-2 Room, Congress Center Basel
About this session
The session aims at continuing the high-level discussion on Drug-Device Combination (DDC) products using Notifed Body opinions (NBOp) and article 117 in MDR from the DIA/RAPS Combination Products Summit in January 2025.
Bringing innovative combination products to the European market is challenging due to divergent/opposing legislation. Innovation is being continuously challenged by a fragmented regulatory system that does not appropriately support the development of products (e.g. convergent technologies) that cut across legislative frameworks.Even though the European Commission, European Medicines Agency, and Head of Medicines Agencies are working to close the gaps and improve the regulatory system, there is an underlying structural challenge which limits innovation and improvement for about a quarter of all treatments under development for European patients.
All presenters will shortly via two slides and 4 minutes present their perspective and experience on EU combination product regulation, followed by a discussion of the key challenges faced by both industry and regulators.
Programme:
- Panel Discussion — Alberto Ganan Jimenez, Michael Kuehler, Celine Bourguignon, Sabina Hoekstra-van den Bosch
- 1. Introduction & Welcome — Thomas Wejs Møller
- 5. Opening Slides — Sabina Hoekstra-van den Bosch
- 4. Opening Slides — Alberto Ganan Jimenez
- 2. Opening Slides — Michael Kuehler
- 3. Opening Slides — Celine Bourguignon
Speakers
-
Head fo Committees and Quality Assurance Department · European Medicines Agency
Speaker
-
Global Director Regulatory Strategy · TÜV SÜD
Speaker
