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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