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Global Clinical Trial Disclosure and Data Transparency Conference
Session 7: Status and Latest News on the EU Regulatory Requirements Related to Disclosure of Clinical Data
Merete Joergensen, MBA, MSc
- Senior Trial Disclosure Director, Clinical Reporting Anchor & Disclosure
- Novo Nordisk A/S, 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
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)
- Scientific Administrator, Compliance and Inspection
- European Medicines Agency, Netherlands
Industry Update: Clinical Disclosure Requirements in Europe
Matthias Zerm, PhD
- Lead Expert, Clinical Trial Disclosure and R&D Processes
- Merz Pharmaceuticals GmbH, Germany
Preconference Short Courses
Check out our 2019 Program!