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Session 1: Latest Updates on Clinical Trial Portal and Its Functionalities
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
Speaker(s)
Updates on EU Clinical Trial Regulation from Member States
Senior EU CT policy adviser, Danish Medicines Agency, Denmark
Updates on EU Clinical Trials Portal
TDA-CTT Change Management Lead, European Medicines Agency, Netherlands
CTIS Project Update from an Industry Perspective
Clinical Trial Transparency & Discosure Lead, BMS, United States
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