Real-world evidence (RWE): A challenge for regulatory agencies discussion of the RWE conference with the network of the european medicine agencies, patients, and experts

Patrick Maison; Mahmoud Zureik; Virginie Hivert; Jesper Kjaer; Roman Hossein Khonsari; Gianluca Trifirõ; Christelle Ratignier-Carbonneil

doi:10.3389/fphar.2022.969091

Real-world evidence (RWE): A challenge for regulatory agencies discussion of the RWE conference with the network of the european medicine agencies, patients, and experts

Front Pharmacol. 2022 Jul 26:13:969091. doi: 10.3389/fphar.2022.969091. eCollection 2022.

Authors

Patrick Maison^{1

2}, Mahmoud Zureik³, Virginie Hivert⁴, Jesper Kjaer⁵, Roman Hossein Khonsari⁶, Gianluca Trifirõ⁷, Christelle Ratignier-Carbonneil¹

Affiliations

¹ ANSM, Paris, France.
² Faculté de Santé, Université Paris-Est Créteil, Créteil, France.
³ Epi-Phare, Saint Denis, France.
⁴ EURORDIS, Paris, France.
⁵ Data Analytics Centre, Danish Medicines Agency, Copenhagen, Denmark.
⁶ Health Data Hub, Paris, France.
⁷ Department of Diagnostics and Public Health, University of Verona, Verona, Italy.

No abstract available

Keywords: big data; patient engagement; pharmacoepidemiology; pharmacovigilance; real-world data (RWD); real-world evidence (RWE); regulatory agencies; regulatory science.