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. 2022 Jan;111(1):21-23.
doi: 10.1002/cpt.2479. Epub 2021 Nov 19.

Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value

Peter Arlett  1 , Jesper Kjaer  2 , Karl Broich  3 , Emer Cooke  1
Affiliations

Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value

Peter Arlett et al. Clin Pharmacol Ther. 2022 Jan.
No abstract available

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Conflict of interest statement

The authors declared no competing interests for this work.

Figures

Figure 1
Figure 1
Big Data Steering Group workplan to 2023. Eleven workstreams to progress the real‐world evidence (RWE) vision.
See this image and copyright information in PMC

References

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    1. European medicines agencies network strategy to 2025 <https://www.ema.europa.eu/en/documents/report/european‐union‐medicines‐a...>.
    1. <https://www.fda.gov/media/120060/download>.
    1. Cave, A. , Kurz, X. & Arlett, P. Real world data for regulatory decision making: challenges and possible solutions for Europe. Clin. Pharmacol. Ther. 106, 36–39 (2019). - PMC - PubMed