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Ep. 26: Facilitate clinical research in Europe
Manage episode 323943015 series 2953454
Content provided by Kathy Vandebelt and Oracle Corporation. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Kathy Vandebelt and Oracle Corporation or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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.
43 episodes
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Manage episode 323943015 series 2953454
Content provided by Kathy Vandebelt and Oracle Corporation. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Kathy Vandebelt and Oracle Corporation or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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.
43 episodes
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