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Session 5: EU Portal: The Gateway to the Implementation of Clinical Trial Regulations
Session Chair(s)
Matthias Zerm, PhD
Lead Expert, Clinical Trial Disclosure and R&D Processes
Merz Pharmaceuticals GmbH, Germany
Interested in the EU Portal and Database? What is it about and how will it work? What is the current status? What is the implementation strategy and related timelines? This session will address these questions and provide insight into the clinical trial disclosure provisions in the EU Clinical Trial Regulation EU (No) 536/2014 and how they are implemented in the EU Portal.
Learning Objective :
Speaker(s)
Virtual Presenter
Ana Rodriguez Sanchez Beato , PhD
European Medicines Agency, Netherlands
Head of Clinical and Non-Clinical Compliance, CTIS expert
Speaker
Matthias Zerm, PhD
Merz Pharmaceuticals GmbH, Germany
Lead Expert, Clinical Trial Disclosure and R&D Processes
Q&A Panel Discusison
Panel Discussion
All Session Speakers, United States
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