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Clinical Trial Regulation Conference

Join experts from regulatory, ethics bodies, sponsors and patients to discuss the launch of the Clinical Trial Regulation and new trends of Clinical Trials in Europe.

Joint Session 1 - Part I: Overview of the EU CTIS

Session Chair(s)

Scott  Feiner

Scott Feiner

  • Senior Project Manager, Disclosure
  • AbbVie, United States
Rose-Marie  Swallow

Rose-Marie Swallow

  • Senior Manager, EU Regulatory Policy & Intelligence
  • Bayer Plc., United Kingdom
With the clock ticking until CTIS go-live and implementation of the Clinical Trial Regulation only 8 weeks away, this opening session aims to get together 3 key stakeholders: EMA, Member States, and Sponsors, to bring us up to speed on how ready they are for 31 January 2022. As well as describing key functionalities of CTIS, this session will highlight any remaining challenges that Sponsors need to be aware of in preparation for this long awaited change in how we handle clinical trial applications in Europe in the future. The session will end with a demonstration of the public view of CTIS in preparation for Part 2.


Laura  Pioppo

Demonstration of EU CTIS – Public View

Laura Pioppo

  • Scientific Administrator, CTIS expert
  • European Medicines Agency, Netherlands
Elke  Stahl, PhD

Update on Member States Readiness

Elke Stahl, PhD

  • CTFG Co-Chair, Clinical Trials expert
  • Federal Institute For Drugs and Medical Devices (BfArM), Germany
Pierre-Frédéric  Omnes, MPharm

Sponsor Perspective

Pierre-Frédéric Omnes, MPharm

  • Executive Director, Site Start-Up & Regulatory
  • Syneos Health, France

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