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 GCP and of clinical research regulations 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 and Drug Development • Planning of Clinical Trials • Conduct and Management of Clinical Trials • Close-out and Reporting of Clinical Trials • Audits and Inspection
Thesis
dir
Prof. Jules DESMEULES, University of Geneva
co
Dr Emilie ALIROL, Ninon HORIE and Corinne CHAUDET, University of Geneva
3rd edition

Duration
October 2013 to September 2014
32 ECTS credits

Application deadline
17 July 2013

Registration fee
CHF 6’500.-
CHF 1’350.- / module
Chèque formation

Information
Clinical Trial Unite
University Hospitals of Geneva
University of Geneva
+41 (0)22 372 91 34

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