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Clinical Trial Regulation Conference
Joint Session 1 - Part I: Overview of the EU CTIS
- Senior Project Manager, Disclosure
- AbbVie, United States
- 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.
Demonstration of EU CTIS – Public View
- Scientific Administrator, CTIS expert
- European Medicines Agency, Netherlands
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
- Executive Director, Site Start-Up & Regulatory
- Syneos Health, France