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Joint Session 2: How does the experience with CTR Transparency implementation shape our future thinking?
Session Chair(s)
Scott Feiner
Senior Manager, Trial Disclosure, AbbVie, United States
Ruediger Pankow, DRSC
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany
The EU CTR has transformed our day-to-day practice in transparency, moving from a handful of documents disclosed at the end of a clinical trial, to disclosure of many clinical trial documents before the trial begins. Building from a few examples of the transparency implementation of the EU CTR, this session explores changes to the overall approach to disclosure, while meeting the privacy requirements for the General Data Protection Regulation (GDPR).
The key aspects for the panel discussion include a coordinated approach to disclosure/transparency:
- For sponsor and authority authored documents
- Across public databases (CTIS, Eudamed, CT.gov)
- That evolves to adjust for future systems/initiatives
Speaker(s)
Laura Pioppo, MSC
ACT EU Programme Manager, European Medicines Agency, Netherlands
Contributing Panellist
Elke Stahl, PHD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
Contributing Panelist
Jesper Kjær, MS
Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk A/S, Denmark
Contributing Panelist
Guido Grass, MD
Ethic Commission, University of Cologne, Germany
Contributing Panelist
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