GetReal Conference 2024: Insights from Session 2 – progress in regulatory decision-making with RWE

In the second session of the GetReal Institute Conference 2024, an expert panel, moderated by Álmath Spooner (AbbVie, Ireland), explored the integration of real-world evidence (RWE) in regulatory decision-making. Panelists included Patrice Verpillat (European Medicines Agency’s [EMA], The Netherlands), Donna Rivera (FDA, USA), Alison Cave (Medicines and Healthcare products Regulatory Agency [MHRA], UK) and Katrien Oude Rengerink (College ter Beoordeling van Geneesmiddelen–Medicines Evaluation Board [CBG-MEB], The Netherlands). EU perspective on RWE Patrice Verpillat discussed the EMA's progress with RWE, noting, "By 2025, our vision is that the use of RWE will be enabled, and its value established across the full...