The European Medicines Agency (EMA) has published the agenda for its upcoming European Platform for Regulatory Science Research meeting, scheduled as a virtual event on 30 April 2026. The meeting aims to connect academic researchers with regulators to advance regulatory science, focusing on research that addresses regulatory needs and fosters translation of outcomes into practical solutions for medicine developers and regulators.
The agenda, released on 28 April 2026, outlines three key sessions. The first session will discuss how public clinical trial registers, such as the Clinical Trials Information System (CTIS), can be used to inform trial design and safety analyses. The second session will cover research and evidence generation for new medicines and repurposing, including EU-level support pathways and researcher case studies. The third session will demonstrate the use of HMA-EMA catalogues of real-world data sources and studies for medicines research.
Connecting researchers and regulators The platform is designed to support research that directly addresses regulatory needs, share best practices, and promote the translation of research outcomes into regulatory tools and guidelines. The target audience includes academic researchers, regulators, and stakeholders involved in drug development and evaluation. The event is part of ongoing efforts by EMA and the Heads of Medicines Agencies (HMA) to strengthen the interface between regulatory science and academic research, aiming to improve the efficiency and quality of medicine evaluation.
Impact on stakeholders The meeting is expected to have a moderate impact on academic researchers by providing direct access to regulatory perspectives and data sources, potentially streamlining research that supports regulatory submissions. For regulators, the platform offers a channel to communicate priority research needs and leverage academic expertise. Medicine developers may benefit indirectly from more targeted research outputs that address regulatory gaps. However, the event is a virtual meeting with no binding outcomes, so its immediate impact is limited to knowledge exchange and networking.
Expected follow-up No formal decisions or regulatory changes are anticipated from this meeting. The outcomes are likely to inform future research priorities and possibly lead to collaborative projects between academia and regulatory bodies. EMA and HMA may publish a summary report or guidance following the event.
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