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CCH - Congress Center Hamburg

Apr 06, 2016 9:00 AM - Apr 06, 2016 12:30 PM

Am Dammtor / Marseiller Str., 20355 Hamburg, Germany

TUT05: EU Risk Management Plans: Using (Pre) Clinical Data to Write the Module SVII of the RMP Part II – Safety Specifications

Instructors

Emil Andrei  Cochino, MD, MHS

Emil Andrei Cochino, MD, MHS

Scientific Senior Specialist (Risk Management), European Medicines Agency, Netherlands

Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Human Medicines Department as a Scientific Senior Specialist (Risk Management), where he is responsible for peer-reviewing risk management plans for Advanced Therapy Medicinal Products. Furthermore, he is overseeing the revision 3 update of GVP Module V – Risk Management Systems and is coordinating the Agency’s transparency efforts for RMPs.

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