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KIT Royal Tropical Institute, Amsterdam

Oct 19, 2022 6:30 PM - Oct 20, 2022 11:30 PM

Mauritskade 63, 1092 Amsterdam, Netherlands

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

Scott Feiner

Senior Manager, Trial Disclosure

AbbVie, United States

Ruediger  Pankow, DrSc

Ruediger Pankow, DrSc

Regulatory Affairs Expert, CTIS SME and PO


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,
  • That evolves to adjust for future systems/initiatives


Laura  Pioppo, MSc

Contributing Panelist

Laura Pioppo, MSc

European Medicines Agency, Netherlands

Scientific Administrator, CTIS expert

Elke  Stahl, PhD

Contributing Panelist

Elke Stahl, PhD

Federal Institute For Drugs and Medical Devices (BfArM), Germany

Senior Expert, Clinical Trials Department

Guido  Grass, MD

Contributing Panelist

Guido Grass, MD

University of Cologne, Germany

Ethic Commission

Jesper  Kjær, MS

Contributing Panelist

Jesper Kjær, MS

Novo Nordisk, Denmark

Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs

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