Vicki Iassonidou

Vicki Iassonidou is Director, Global Regulatory Clinical Services, ICON, Munich, Germany.

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


    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 ...