The EU project Real4Reg: unlocking real-world data with AI

Abstract Background The use of real-world data is established in post-authorization regulatory processes such as pharmacovigilance of drugs and medical devices, but is still frequently challenged in the pre-authorization phase of medicinal products. In addition, the use of real-world data, even in p...

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Main Authors: Jonas Peltner, Cornelia Becker, Julia Wicherski, Silja Wortberg, Mohamed Aborageh, Inês Costa, Vera Ehrenstein, Joana Fernandes, Steffen Heß, Erzsébet Horváth-Puhó, Monika Roberta Korcinska Handest, Manuel Lentzen, Peggy Maguire, Niels Henrik Meedom, Rebecca Moore, Vanessa Moore, Dávid Nagy, Hillary McNamara, Anne Paakinaho, Kerstin Pfeifer, Liisa Pylkkänen, Blair Rajamaki, Evy Reviers, Christoph Röthlein, Martin Russek, Célia Silva, Dirk De Valck, Thuan Vo, Elvira Bräuner, Holger Fröhlich, Cláudia Furtado, Sirpa Hartikainen, Aleksi Kallio, Anna-Maija Tolppanen, Britta Haenisch
Format: Article
Language:English
Published: BMC 2025-02-01
Series:Health Research Policy and Systems
Online Access:https://doi.org/10.1186/s12961-025-01287-y