EMA provides mid-point progress report on real-world evidence development strategies

A new report from the E.U. Big Data Steering Group (BDSG), EMA, and the European Medicines Regulatory Network (EMRN) shares experience obtained from real-world data (RWD) based studies between September 2021 and February 2023. This study was developed to help establish a workable framework for using real-world evidence (RWE) for regulatory cases within the E.U., building off the EMA’s Strategy through 2025.

Background: Real-world data (RWD) and evidence (RWE) for regulatory use in the E.U.

What is real-world data (RWD) and evidence (RWE)?

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