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New European Clinical Trial Regulation: A New Paradigm with Major Impact on Clinical Trial Stakeholders
Session Chair(s)
Elke Stahl, PhD
Senior Expert, Clinical Trials Department
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Are stakeholders ready for implementation of the EU Clinical Trial Regulation? Challenges, expectations and progress update by members states, EMA and industry.
Speaker(s)
Update on Member State Preparations for Implementing the Clinical Trial Regulation, and Some of the Outstanding Challenges
Martyn Ward, DrMed
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Group Manager Licensing
Progress Update on the Development of the EU Portal and Database
Fergus Sweeney, PhD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force
How Industry is Adapting Itself to Meet the Requirements of the New Clinical Trial Regulation
Rose-Marie Swallow
Bayer Plc., United Kingdom
Senior Manager, Policy & Research
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