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Management of Clinical Trials

DAS

Université de Genève (UNIGE)

Catégories
Lieu de formation

Genève (GE)

Langue d'enseignement

anglais - français

Type de formation

Hautes écoles universitaires HEU - Formation continue: formations longues

Modalités temporelles

À temps partiel

Thèmes de formation

Santé, soins, médecine

Domaines d'études

Médecine humaine

Swissdoc

7.724.4.0

Mise à jour 26.08.2019

Description

Description de la formation

Program in 8 modules: 

  • Principles and Methods in Clinical Research
  • Ethical and Legal Aspects
  • 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

+ Thesis

Objectives

  • Provide essential knowledge and understanding of drug development and marketing authorization processes
  • Enable participants to understand issues related to human subject research
  • Describe the different clinical trial designs and methodologies
  • Give a theoretical and practical insight on project planning and management in clinical trials
  • Provide effective tools to comply with clinical research regulations and Good Clinical Practices (GCP)
  • Enable participants to successfully manage trial applications to ethics committees and regulatory authorities
  • Illustrate how to implement quality systems in clinical trials

Admission

Conditions d’admission

  • Title of physician or master’s or bachelor’s degree in Life Science or title deemed equivalent;
  • Or Bachelor’s degree from a Swiss University of Applied Sciences (HES) plus a minimum of 1 year professional experience in the field of the DAS;
  • Good understanding of both French (knowledge equivalent to B2
    Level) and English (knowledge equivalent to the Cambridge First
    Certificate)
  • The candidates who follow the programme during their working time
    must provide written authorization from their employer.

Admission sur dossier.

Audience

Medical doctor, biologist, pharmacist, nurse, biochemist and other professional involved, or wishing to gain skills and knowledge, in the field of clinical research.

Coûts

CHF 7’500.-
CHF 1’500.- (individual module)

Diplôme

  • Diploma of Advanced Studies DAS

DAS in Management of Clinical Trials – Good Clinical Practice Implementation and Quality Processes / DAS en Gestion des essais cliniques – Mise en application des bonnes pratiques et processus qualité, delivered by the University of Geneva.
33 ECTS (European Credit Transfer and Accumulation System) credits.

Infos pratiques

Lieu / adresse

  • Genève (GE)

Fondation Louis Jeantet
77 route de Florissant
1208 Genève

Déroulement temporel

Début des cours

September

Durée de la formation

1 year
Approximately 24 hours of teaching per module over one year.

Modalités temporelles

  • À temps partiel

Langue d’enseignement

  • anglais
  • français

Remarques

The course is accredited by Swissethics, the Swiss Association of Pharmaceutical Professionals, the Swiss Society of Clinical Pharmacology and Toxicology and the Swiss Institute for postgraduate and continuous medical education.

Liens

Renseignements / contact

Tel. : +41 (0)22 372 99 34
E-mail: DAS.Clinicaltrials@hcuge.ch

orientation.ch