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Session 4: Latest Updates on Clinical Trial Disclosure in the EU and USA
Session Chair(s)
Matthias Zerm, PHD
Lead Expert, Clinical Trial Disclosure and R&D Processes, Germany
Are you aware of the latest clinical trial disclosure updates in the USA and the EU? This session will present updates from ClinicalTrials.gov, inform about the implementation of the EU Portal and Database (in the context of the EU Clinical Trial Regulation), and provide insights into the ongoing expansion of the Eudamed database to accommodate the functionalities around clinical studies with medical devices along with pertinent transparency provisions as required by the EU Medical Device Regulation.
Speaker(s)
Updates from NIH/ClinicalTrials.gov
Senior Clinical Trials Subject Matter Expert, Essex Management, Part of Emmes Group, United States
Anabela Marcal, PHARMD
EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
Updates on MDR: Transparency Provisions and Eudamed Expansion (Clinical Module)
Senior Global Regulatory Consultant, EMERGO, Netherlands
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