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: Preclinical Pharmacology, Toxicology and Clinical Pharmacology • Safety Management and Drug Development • Principles and Methods of Clinical Research • Ethical and Legal Aspect • Planning of Clinical Trials • Conduct and Management of Clinical Trials • Close-out and Reporting of Clinical Trials • Audits and Inspections
Research paper
Director
Prof. Jules DESMEULES, Faculty of Science and Faculty of Medicine, University of Geneva
Coordination
Victoria ROLLASON, Amita SEHMI GUIGOZ, University Hospitals of Geneva (HUG)
The course is accredited by Swissethics, the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society of Clinical Pharmacology and Toxicology
7th edition

Duration
September 2017 to September 2018
32 ECTS credits

Registration deadline
DAS: 15 June 2017
or one month prior to the beginning of the selected module

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

Applcation for a single module of 2016-2017 edition:

ONLINE APPLICATION >>

APPLICATION FORM  (PDF)

Registration Module 7

About the MAS - Drug Discovery and Clinical Development >>

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