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Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Session 5: EU Portal: The Gateway to the Implementation of Clinical Trial Regulations

Session Chair(s)

Matthias  Zerm, PhD

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 :
  • Recognize the central role of the EU portal for clinical trials in Europe
  • Identify on the current status and implementation timelines of the EU Clinical Trial Regulation
  • Summarize the clinical trial disclosure provisions in the EU Clinical Trial Regulation and how they will be implemented via the EU Portal
  • Speaker(s)

    Ana  Rodriguez Sanchez Beato , PhD

    Virtual Presenter

    Ana Rodriguez Sanchez Beato , PhD

    • Head of Clinical and Non-Clinical Compliance
    • European Medicines Agency, Netherlands
    Matthias  Zerm, PhD

    Speaker

    Matthias Zerm, PhD

    • Lead Expert, Clinical Trial Disclosure and R&D Processes
    • Merz Pharmaceuticals GmbH, Germany
      Panel Discussion

    Q&A Panel Discusison

    Panel Discussion

    • All Session Speakers, United States

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    Short Course 1

    Disclosures 101


    Short Course 2

    Preparing Documents for Disclosure and Public Sharing 


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