Implementation of Regulation (EU) No 536/2014 – A CRO perspective

By Ana Velimirovic, Britta Dieckhoff, Elisaveta Parapiteva, Iris Romero Matuschek, Polly Halliday and Vicki Iassonidou2023-06-23T14:00:00

Significant changes have been implemented to the clinical trials application process with Regulation (EU) No 536/2014 (European Union Clinical Trials Regulation; EU CTR) taking effect on 31 January 2022. This article summarises experience gathered under the new regulatory framework from a contract research organisation (CRO) perspective working with pharma and ...

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