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Session 7: Status and Latest News on the EU Regulatory Requirements Related to Disclosure of Clinical Data
Session Chair(s)
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark
An overview of the EU Regulatory scene seen in the perspective of Clinical Transparency and Disclosure. The presentations will focus on the status and recent development in EU, including the upcoming EU Clinical Trials Regulation, the development of the IT system CTIS (Clinical Trials Information System), the latest and upcoming development initiatives for the EudraCT system, and Brexit implications on its future functionality. The industry perspective on preparation for the new requirements including also the new database for device trials.
Learning Objective : At the conclusion of this session, participants should be able to:- Analyze and prepare for their organization’s process for the upcoming Clinical Trials Regulation
- Describe the changes in EudraCT and the practical implications
- Discuss the industry perspective on the implementation and knowledge on transparency in relation to devices
Speaker(s)
Regulatory Update: Status of the Implementation of EU Clinical Trials Regulation, Clinical Trials Information System (CTIS), and Other Important EU Clinical Transparency News (Remote Presentation)
Noemie Manent, PharmD
European Medicines Agency, Netherlands
TDA-CTT Operations Workstream Lead
Industry Update: Clinical Disclosure Requirements in Europe
Matthias Zerm, PhD
Merz Therapeutics GmbH, Germany
Lead Expert, Clinical Trial Disclosure and R&D Processes
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