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