A vision for use of real world evidence in EU medicines regulation

EMA

24 November 2021 - Enabling the use of real world evidence and establishing its value for regulatory decision-making on the development, authorisation and supervision of medicines in Europe by 2025. 

This is the vision of European regulators as outlined in an article from Peter Arlett, Head of Data Analytics and Methods at EMA, Jesper Kjær, Director of Data Analytics Centre at the Danish Medicines Agency, Karl Broich, President of the Federal Institute for Drugs and Medical Devices, and Emer Cooke, EMA's Executive Director, published in Clinical Pharmacology & Therapeutics.

Read EMA press release

Michael Wonder

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Michael Wonder