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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
  • Merz Pharmaceuticals GmbH, 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)

Rebecca  Williams, PharmD, MPH

Updates from NIH/ClinicalTrials.gov

Rebecca Williams, PharmD, MPH

  • Acting Director, ClinicalTrials.gov, NCBI
  • National Library of Medicine, NIH, United States
Anabela  Marcal, PharmD

Anabela Marcal, PharmD

  • Head of Committees and Inspections Department
  • European Medicines Agency, Netherlands
Ronald  Boumans

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

Ronald Boumans

  • Senior Global Regulatory Consultant
  • EMERGO, Netherlands