BIO-Europe 2026
Talk Regulatory Strategy track
What is the Future of Real-World Evidence (RWE) in Europe?
Wed, Nov 11, 2026 · 11:30 AM–12:00 PM CET Regulatory Strategy Stage, Koelnmesse
About this session
Update on Darwin Project: full data pilot for non-interventional studies Member States’ independent approaches to RWE and its impact on EU-wide consistency Intersection of Darwin and EHDS: navigating global transparency and data-sharing challenges Addressing regulatory questions in pre- and post-marketing spaces with RWE