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Millennium Hotel London Mayfair

Dec 05, 2017 8:30 AM - Dec 06, 2017 6:30 PM

44 Grosvenor Square Mayfair, London, W1K 2HP, United Kingdom

Clinical Trial Regulation Conference

Session 4: Implementation and Readiness

Session Chair(s)

Elke  Stahl, PhD

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

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

Greet  Musch, PhD

Feedback from Pilots from Selected European Countries: Belgium

Greet Musch, PhD

FAMHP, Belgium

strategic adviser

Lucie  Kravackova, DrMed

Feedback from Pilots from Selected European Countries: Czech Republic

Lucie Kravackova, DrMed

State Institute for Drug Control (SUKL), Czech Republic

Senior Clinical Assessor

Monique  Al, PhD

Ethics Perspective: The Netherlands

Monique Al, PhD

Central Committee on Research Involving Human Subjects (CCMO), Netherlands

Special advisor CCMO

Karen  Kiilerich

Ethics Perspective: Denmark

Karen Kiilerich

The National Committee on Health Research Ethics , Denmark

Special Legal Consultant

Rose-Marie  Swallow

CTR Implementation Readiness – Sponsor’s Perspective

Rose-Marie Swallow

Bayer Plc., United Kingdom

Senior Manager, Policy & Research

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