Cargando…
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...
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 |
Ejemplares similares
-
Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe
por: Jonker, Carla J., et al.
Publicado: (2022) -
EU-funded initiatives for real world evidence: descriptive analysis of their characteristics and relevance for regulatory decision-making
por: Plueschke, Kelly, et al.
Publicado: (2018) -
Precision medicine in regulatory decision making: Biomarkers used for patient selection in European Public Assessment Reports from 2018 to 2020
por: Bakker, Elisabeth, et al.
Publicado: (2023) -
Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?
por: Flynn, Robert, et al.
Publicado: (2021) -
Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020
por: Bakker, Elisabeth, et al.
Publicado: (2022)