Clinical Trial Regulation Conference

This conference provides a forum for information exchange and discussion on conceptual and practical questions about critical issues affecting sponsors and Member States regarding the implemention the regulation.

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SESSION 7: KEY ELEMENTS OF CT DATA TRANSPARENCY IN THE EU

Session Chair(s)

Matthias Zerm, PhD

Lead Expert, Clinical Trial Disclosure and R&D Processes, Merz Therapeutics, Germany

Get an overview of how transparency is reflected in all regulations and policies - EU CTReg, Paediatric Regulation,Data Protection Regulation and Policy 70 – and how it all comes together.

Speaker(s)

Implementation of the Clinical Trial Disclosure Provisions of the CTReg

Emma Du Four, MBA

Independent Regulatory and R&D Policy Professional, Independent, United Kingdom

Mandatory Disclosure of Clinical data in the EU

Christian Fulda

Lawyer, Jones Day, Germany