Talk Data Science, RWE & Artificial Intelligence track
S0303 - Use of RWE for Regulatory Decision Making
Wed, Mar 19, 2025 · 8:30–9:40 AM CET Montreal Room, Congress Center Basel
About this session
How is real-world evidence (RWE) shaping regulatory decision-making today? This session will explore the practical use of RWE across the medicinal product lifecycle, examining its impact on regulatory decisions. Experts from Swissmedic, EMA, and Sanofi will share their experiences and insights on leveraging large-scale RWE analyses for regulatory purposes. Additionally, the session will delve into the evolving data-sharing environment, focusing on the interplay between DARWIN and the European Health Data Space (EHDS), and how these EU legislative and policy initiatives are connected to enhance data utility in regulatory contexts.
Programme:
- 1. Perspective as Head of the German Health Authority and Developments in Germany — Karl Broich
- Panel Discussion — Leonie Rudofsky
- 2. RWE use throughout medicinal product life cycle: experience so far and impact on regulatory decision making — Patrice Verpillat
- 3. Real-World Data & Analytics at Scale in Regulatory & HTA Decision Making — Amaia Clemente
- 4. Evolving Data Sharing Environment — Aneta Tyszkiewicz
Speakers
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Co-Chair Working Group Real World Evidence, Deputy Head of Unit Haematology & Oncology, Clinical Assessment · Swissmedic
Panelist
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Director Data Digital · EFPIA - European Federation of Pharmaceutical Industries and Associations
Speaker
