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THE ROLE OF THE NEW CLINICAL TRIAL LEGISLATION
Session Chair(s)
Lidia Retkowska-Mika, LLM
Director Legal DPT
Office For Registration of Med. Products, Medical Devices and Biocides, Poland
The objective of the session is to present and discuss major changes in the overall approach, assessment, approval and conduct of clinical trials in the EU introduced in the new legislation. New definitions, new procedures for sponsors and Member States, the role of ethics committees, new IT tools established in the legislation will be presented with the view to inspire discussion on the forthcoming challenges and the use of new legal instruments to make the EU a more attractive area for the conduct of clinical trials.
Speaker(s)
Key Content of the New Clinical Trial Legislation- setting the scene
Lidia Retkowska-Mika, LLM
Office For Registration of Med. Products, Medical Devices and Biocides, Poland
Director Legal DPT
EMA Preparedness for the Implementation of the New Legislation
Ana Rodriguez Sanchez Beato , PhD
European Medicines Agency, Netherlands
Head of Clinical and Non-Clinical Compliance, CTIS expert
Challenges in the Ethical Review of Clinical Trial Application
Wojciech Maselbas, MD
Association for the Good Clinical Practice in Poland, Poland
Vice-President
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