DAS - Management of Clinical Trials

objectives
Understand the different Clinical Trial designs and methodologies
Be familiar with drug development and marketing authorization processes
Gain knowledge of clinical research regulations and of GCP in Switzerland, Europe and the United States
Become skilled at writing clinical protocols and developing Case Report Form (CRF)
Master effective project planning and management
Know how to manage applications for Ethics Committee (EC) and Regulatory Authority (RA)
Learn about Quality Control (QC) and Quality Assurance (QA) systems for Clinical Trials
Understand the issues related to research subject protection
audience
Medical doctors, biologists, pharmacists, nurses, biochemists and other professionals involved or wishing to gain skills and knowledge in the field of clinical research
programme
7 modules: Principles and Methods of Clinical Research • Ethical and Regulatory Aspect • Safety Management during drug development • Planning of Clinical Trials • Conduct and Management of Clinical Trials • Close-out and Reporting of Clinical Trials • Audits and Inspections • Thesis
dir
Prof. Jules DESMEULES, University of Geneva
co
Emilie ALIROL and Corinne CHAUDET, University of Geneva
2nd edition
Programme >>
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Duration
October 2012 to September 2013
32 ECTS credits

Applications are closed

Registration fee
CHF 1’350.- / module

Information
Centre de Recherche Clinique, Faculté de Médecine, Université de Genève et Hôpitaux Universitaires de Genève
+41 (0)22 372 91 34

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