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Post-graduate Diploma in Management of Clinical Trials

An essential step for transitioning your career to clinical research

In the past two decades, the number of Clinical Trials conducted in Switzerland and worldwide has virtually exploded. This tremendous increase went hand in hand with the development of codes, guidelines and regulations aimed at protecting human research subjects. Standardization and strengthening of clinical research regulations have led to the development of a rapidly growing economic sector in which Clinical Research Associates (CRA), Clinical Research Scientists (CRS), Data Managers (DM), Clinical Research Coordinators (CRC), Clinical TrialManagers (CTM) and regulatory affairs specialists are key players.

The Diploma of Advanced Studies (DAS) in Management of Clinical Trials provides a theoretical and practical understanding of how Good Clinical Practice (GCP) principles are shaping each step of a Clinical Trial, including study design, trial management and conduct.

Programme Direction

Prof. Jules Desmeules, Head of Clinical Pharmacology and Toxicology unit, Head of the Clinical Trial Unit, Clinical Research Center, University Hospitals of Geneva, Faculty of Medicine, University of Geneva

Coordination

Dr Victoria Rollason, Programme Coordinator, PharmD, PhD, Division of Clinical Pharmacology and Toxicology and Clinical Trials Unit, University Hospitals of Geneva, Faculty of Medicine, University of Geneva

Ms Amita Sehmi Guigoz, Administrative Assistant, Hospitals of Geneva, Faculty of Medicine, University of Geneva.

Ms Corinne Chaudet, Assistant of the Clinical Trial Unit, Clinical Research Center,University Hospitals of Geneva, Faculty of Medicine, University of Geneva.

Topics

  • Methodology of clinical trials, data management and analysis
  • Ethical principles of clinical research, regulations applicable to clinical research in Switzerland, Europe and the United States
  • Project management and coordination in clinical research
  • Quality systems in clinical research
  • Safety aspects of drug development, pharmaco-vigilance and pharmaco-epidemiology
  • Drug development and marketing authorization process