Menu Back toSession-7-Status-and-Latest-News-on-the-EU-Regulatory-Requirements-Related-to-Disclosure-of-Clinical-Data

Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest global requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Session 7: Status and Latest News on the EU Regulatory Requirements Related to Disclosure of Clinical Data

Session Chair(s)

Merete  Joergensen, MBA, MSc

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

Speaker(s)

Noemi  Manent

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)

Noemi Manent

  • Scientific Administrator, Compliance and Inspection
  • European Medicines Agency, Netherlands
Matthias  Zerm, PhD

Industry Update: Clinical Disclosure Requirements in Europe

Matthias Zerm, PhD

  • Lead Expert, Clinical Trial Disclosure and R&D Processes
  • Merz Pharmaceuticals GmbH, Germany