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Mar 28, 2022

The European Union (EU) has been on a path to harmonize the clinical trial process and requirements since 2004 starting with the Directive. The next step came 10 years later, in 2014, with the Clinical Trial Regulation (CTR). This year, as of January 31, the Clinical Trials Information System (CTIS) went live and supports the flow of information between clinical trial sponsors, EU Member States, European Economic Area (EEA) countries and the European Commission. In this episode, Marieke Meulemans from GCP Central and Sebastian Payne from Deloitte share how clinical research and patient health in the EU will benefit from the streamlined regulatory processes and a new portal.