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Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making

Real‐world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been recognized for safety monitoring and disease epidemiology across medicines' life cycles, using RWD/RWE to demonstrate efficacy...

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Detalles Bibliográficos
Autores principales: Bakker, Elisabeth, Plueschke, Kelly, Jonker, Carla J., Kurz, Xavier, Starokozhko, Viktoriia, Mol, Peter G. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10099093/
https://www.ncbi.nlm.nih.gov/pubmed/36254408
http://dx.doi.org/10.1002/cpt.2766