Talk Regulatory Strategy & EU Pharmaceutical Policy track
S0901 - Multistakeholder Collaboration to Drive Regulatory Science in Europe
Tue, Mar 18, 2025 · 3:10–4:20 PM CET Montreal Room, Congress Center Basel
About this session
Regulatory Science provides a foundation for evidence-based regulatory innovation. For several years pre-competitive consortia including IMI have employed regulatory science approaches to deliver innovative tools and methodologies to improve efficiency and reduce development timelines for medicine development, while maintaining quality, safety and efficacy standards. As the projects are product agnostic they may be generalisable, and derisk new processes. Applying lessons learned from these past experiences to shape future activities is at the heart of this session.
By examining the current state of play for regulatory science and innovation in Europe, as well as identifying critical questions for the future, the session will explore the conditions and opportunities for building a more optimal collaboration infrastructure in Europe. It will also highlight best practices, practical experience, and steps towards collaboration in regulatory science research.
Translation of project outputs into regulatory acceptability is often critical for the outputs to be considered by developers in their R&D strategies and to gain the maximum value from the project. At the same time success often relies on intermediaries who were not directly involved in a project and on navigating a complex policy environment, rather than on having direct control over implementation. The session will consider the level of regulatory engagement/ acceptance that pre-competitive projects may need, and explore how successful different approaches to engage regulators and other health system stakeholders have been.
Programme:
- 1. Reflections on what has been learned from over 200 IMI/IHI projects that have helped to advance regulatory science — Nathalie Seigneuret
- 2. How the Regulatory Science Research Network in The Netherlands has contributed to advancing regulatory science? — Sophie Huiskes-Berends
- Panel Discussion — Ralf Herold, Sophia Samodelov, Nick Sykes
Speakers
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IHI TransBioLine Consortium Project Coordinator · University Hospital Zurich
Panelist
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Head Science Department / Associate Professor of Drug Regulatory Science · Medicines Evaluation Board / Utrecht University
Chair
