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Hilton London Docklands Riverside Hotel

Sep 19, 2018 8:00 AM - Sep 20, 2018 5:00 PM

265 Rotherhithe Street , London, SE16 5HW, United Kingdom

Global Clinical Trials Transparency Conference

Session 4: Latest Updates on Clinical Trial Disclosure in the EU and USA

Session Chair(s)

Matthias  Zerm, PhD

Matthias Zerm, PhD

Lead Expert, Clinical Trial Disclosure and R&D Processes


Are you aware of the latest clinical trial disclosure updates in the USA and the EU? This session will present updates from, 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.


Rebecca  Williams, PharmD, MPH

Updates from NIH/ Rebecca Williams, PharmD, MPH

Senior Clinical Trials Subject Matter Expert

Essex, an Emmes Company, United States

Anabela  Marcal, PharmD

Anabela Marcal, PharmD

EMA Liaison Official to the US FDA

European Medicines Agency, Netherlands

Ronald  Boumans

Updates on MDR: Transparency Provisions and Eudamed Expansion (Clinical Module): Ronald Boumans

Senior Global Regulatory Consultant

EMERGO, Netherlands

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