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Clinical Trials and Data Science Conference
Joint Session 2: How does the experience with CTR Transparency implementation shape our future thinking?
Session Chair(s)
Scott Feiner
- Senior Manager, Clinical Records Management, Strategic Clinical Operations
- AbbVie, United States
Ruediger Pankow, DrSc
- Principal Consultant, Regulatory Affairs
- Parexel International, 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)
Contributing Panelist
Laura Pioppo
- Scientific Administrator, CTIS expert
- European Medicines Agency, Netherlands
Contributing Panelist
Elke Stahl, PhD
- Senior Expert, Clinical Trials Department
- Federal Institute For Drugs and Medical Devices (BfArM), Germany
Contributing Panelist
Guido Grass, MD
- Ethic Commission
- University of Cologne, Germany
Contributing Panelist
Jesper Kjær, MS
- Co-Chair, EMA/HMA Big Data Steering Group; Director of Data Analytics Centre
- Danish Medicines Agency (DKMA), Denmark
