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Session 4: Implementation and Readiness
Session Chair(s)
Elke Stahl, PHD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
How ready are the member states for the upcoming CT Regulation? There are different approaches to implement the CT Regulation throughout EU/EEA, with resulting challenges to solve. First experiences on national pilot projects, where the cooperation between national competent authority and ethics committees is being tested, are gained. A general overview on the national implementation status in EU will be given. Selected NCAs and ECs will give an inside in their MS’s approach, first experiences and challenges from their viewpoint. In addition an update on sponsor’s changes to CT application and also managing of an approved trial, identified critical issues and experiences with national pilots from a sponsor’s view will be presented.
Speaker(s)
Elke Stahl, PHD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
Updates from Member States: General Overview & Traffic Light Readiness
Greet Musch, PHD
strategic adviser , FAMHP, Belgium
Feedback from Pilots from Selected European Countries: Belgium
Lucie Kravackova, DrMed
Senior Clinical Assessor, State Institute for Drug Control (SUKL), Czech Republic
Feedback from Pilots from Selected European Countries: Czech Republic
Monique Al, PHD
Special advisor CCMO, Central Committee on Research Involving Human Subjects (CCMO), Netherlands
Ethics Perspective: The Netherlands
Karen Kiilerich
Special Legal Consultant, The National Committee on Health Research Ethics , Denmark
Ethics Perspective: Denmark
Rose-Marie Swallow
Senior Manager, Policy & Research, Bayer Plc., United Kingdom
CTR Implementation Readiness – Sponsor’s Perspective
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