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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
Rebecca Williams, PHARMD, MPH
Essex, part of Emmes Group, United States
Senior Clinical Trials Subject Matter Expert
Anabela Marcal, PHARMD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
Updates on MDR: Transparency Provisions and Eudamed Expansion (Clinical Module)
Ronald Boumans
EMERGO, Netherlands
Senior Global Regulatory Consultant