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.

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

Session Chair(s)

Matthias Zerm, PhD

Lead Expert, Clinical Trial Disclosure and R&D Processes

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)

Virtual Presenter

Ana Rodriguez Sanchez Beato , PhD

European Medicines Agency, Netherlands

Head of Clinical and Non-Clinical Compliance, CTIS expert

Speaker

Matthias Zerm, PhD

Germany

Lead Expert, Clinical Trial Disclosure and R&D Processes

Q&A Panel Discusison

Panel Discussion

All Session Speakers, United States

Clinical Trial Disclosure and Data Transparency Conference

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

Session Chair(s)

Matthias Zerm, PhD

Speaker(s)

Virtual Presenter

Speaker

Q&A Panel Discusison

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