DAS - Management of Clinical Trials

Objectives
Understand and use in a relevant context 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 developing Case Report Form (CRF)
Coordinate the development of clinical trial protocols
Master effective project planning and management
Know how to manage applications for Ethics Committee (EC) and Regulatory Authority (RA)
Understand and implement Quality Systems used in Clinical Trials
Understand the issues related to research subject protection
Audience
Medical doctor, biologist, pharmacist, nurse, biochemist and other professional involved or wishing to gain skills and knowledge in the field of clinical research
Programme
8 modules: Principles and Methods of Clinical Research •  Ethical and Legal Aspect • Preclinical Pharmacology, Toxicology and Clinical Pharmacology • Safety Management and Drug Development • Clinical Trials Set-up and Conduct – Part 1 • Clinical Trials Set-up and Conduct – Part 2 • Clinical Trials Close-out and Reporting • Audits and Inspections
Research paper
Director
Prof. Jules DESMEULES, Faculty of Science and Faculty of Medicine, University of Geneva
Coordination
Dr Victoria ROLLASON, Amita SEHMI GUIGOZ, University Hospitals of Geneva (HUG)
The course is accredited by Swissethics, the Swiss Association of Pharmaceutical Professionals (SwAPP), the Swiss Society of Clinical Pharmacology and Toxicology and the Swiss Institute for postgraduate and continuous medical education
(SWIF-ISFM).
7th edition

Duration
September 2017 to September 2018
32 ECTS credits

Registrations are closed

Registration fee
CHF 7’500.- for the diploma
CHF 1’500.- for individual modules
Chèque formation

Information
HUG
+41 (0)22 372 91 95
DAS.clinicaltrials(at)hcuge.ch

WEBSITE
drugdevelopment.unige.ch

 

Programme >>clinicaltrials.png

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