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

Author:

Arlett Peter1,Kjær Jesper2,Broich Karl3,Cooke Emer1

Affiliation:

1. European Medicines Agency Amsterdam Netherlands

2. Danish Medicines Agency Copenhagen Denmark

3. BfArM Bonn Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference14 articles.

1. Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?;Flynn R.;Clin. Pharmacol. Ther.,2022

2. Considerations for pharmacoepidemiological analyses in the SARS‐CoV ‐2 pandemic

3. European medicines agencies network strategy to 2025.

4. .

5. Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe

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