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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)
Updates from Member States: General Overview & Traffic Light Readiness
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department
Feedback from Pilots from Selected European Countries: Belgium
Greet Musch, PhD
FAMHP, Belgium
strategic adviser
Feedback from Pilots from Selected European Countries: Czech Republic
Lucie Kravackova, DrMed
State Institute for Drug Control (SUKL), Czech Republic
Senior Clinical Assessor
Ethics Perspective: The Netherlands
Monique Al, PhD
Central Committee on Research Involving Human Subjects (CCMO), Netherlands
Special advisor CCMO
Ethics Perspective: Denmark
Karen Kiilerich
The National Committee on Health Research Ethics , Denmark
Special Legal Consultant
CTR Implementation Readiness – Sponsor’s Perspective
Rose-Marie Swallow
Bayer Plc., United Kingdom
Senior Manager, Policy & Research
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