EMA/HMA – Publication of the Guidance on real-world evidence provided by EMA: support for regulatory decision-making
The EMA jointly with the HMA issued a guide on how it can help generate real-world evidence.
This document briefly describes how RWE, derived from the analysis of RWD, can be useful in the context of regulatory decision-making, the types of studies that can be performed and how EMA can help identify the best resources to address a research question. The process for requesting RWD studies is also explained.
More information on the EMA’s actions on real-world evidence on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (3 octobre 2024). EMA/HMA – Publication of the Guidance on real-world evidence provided by EMA: support for regulatory decision-making. ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/12ezw
