Roundtable Innovative Therapies, Precision Medicine & Diagnostics track
S0504 -IVDR Revision - Needs from a Medicines Development Perspective
Thu, Mar 20, 2025 · 10:30–11:40 AM CET Singapore Room, Congress Center Basel
About this session
The growing integration of science and technologies through the development of personalised medicines is driving a significant increase in development programs and clinical trials incorporating medicines, in-vitro diagnostics (IVDs), and/or medical devices (MDs). This is leading to an increased focus on the interplay between the medicinal product legislation and the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). In particular, the IVDR introduced new requirements that impact the development of Medicines in the EU. The implementation of MDR and IVDR have proven to be challenging and slower than expected. Following stakeholders concerns and a resolution from the European Parliament voted on 23 October 2024 on the urgent need to revise the Medical Devices Regulation, the European Commission has launched a targeted evaluation of the MDR and IVDR in view of proposing appropriate legislative and non-legislative measures.
In this session, after a short setting up of the scene, there will be breakout sessions to discuss what needs to change within IVDR to facilitate development of Medicines in the European Union. The discussions will be guided by representatives from EMA, Healthcare professionals and Industry representatives and will tackle the following themes: early stage medicines clinical research, consolidated scientific advice, coordination in combined Clinical trials and coordination in the regulatory pathway for Personalised medicines.
Programme:
- 1. Introduction and Scene Setting — Adriana Racolta, Celine Bourguignon
- Group 1: Roundtable Topic: How can IVDR revision foster early-stage medicines clinical research? — Mike Wierzba, Elizabeth Macintyre
- Group 2: How could scientific advice be more beneficial in medicines or combined clinical research? — Alberto Ganan Jimenez, Claudia Popp
- Group 3: How can IVDR Revision bring more Coordination in a Clinical trials environment? — Ana Trullás Jimeno, Celine Bourguignon
- Group 4: How could IVDR revision improve the coordination and/or alignment between Personalized Medicines and IVDs/Companion Diagnostics regulatory pathways ? — Ditte Zerlang Andersen, Adriana Racolta
Speakers
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Head fo Committees and Quality Assurance Department · European Medicines Agency
Speaker
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Head EU Regulatory Science & EMA Liaison · Roche
Speaker
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Sr Director, Global Regulatory Leader IVD · Bayer
Chair
