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Management of Clinical Trials

DAS

Université de Genève (UNIGE)

Catégories
Lieu de formation

Genève (GE)

Langue d'enseignement

anglais

Type de formation

Hautes écoles universitaires HEU - Formation continue: formations longues

Modalités temporelles

À temps partiel

Thèmes de formation

Santé, soins, médecine

Filières d'études

Médecine humaine

Swissdoc

7.724.4.0

Mise à jour 07.07.2025

Description

Description de la formation

Le Diploma of Advanced Studies (DAS) est une formation postgrade donnée par les hautes écoles et elle équivaut à au moins 30 crédits ECTS. Le DAS in Management of Clinical Trials équivaut à 33 crédits ECTS.

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

Plan de la formation

1 crédit ECTS correspond à environ 25-30 heures de travail.

Programme

9 modules

  • Principles and Methods of Clinical Research
  • Ethical and Regulatory Aspects
  • Non-Clinical Development and Clinical Pharmacology
  • Safety Management During Product Development
  • Clinical Trial Planning and Set-up
  • Clinical Trial Conduct and Close-Out
  • Audits and Inspections
  • Chemistry, Manufacturing and Controls (optional)
  • Clinical Development and Anti-Cancer and Anti-Infective Vaccines (optional)
  • Medical Devices

+ Thesis

Admission

Conditions d’admission

Admission Criteria

  • Medical degree (physician title), or
  • Master’s or Bachelor’s degree in Life Sciences or an equivalent qualification, or
  • Bachelor’s degree from a Swiss University of Applied Sciences plus at least one year of relevant professional experience
  • Good command of English (level B2–C1)

Candidates attending the programme during working hours must provide written authorisation from their employer.

Audience

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

Coûts

Fees:

  • CHF 9'000.– for the whole DAS

For individual modules:

  • 1-day module: CHF 1'000.-
  • 2-day module: CHF 1'400.-
  • 3-day module: CHF 1'800.-

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 cliniques et processus qualité (33 ECTS credits), University of Geneva.

Infos pratiques

Lieu / adresse

  • Genève (GE)

Format: On-site.

Déroulement temporel

Début des cours

September.

Durée de la formation

A minimum of 2 semesters and a maximum of 4 semesters.

Modalités temporelles

  • À temps partiel

Langue d’enseignement

  • anglais

Remarques

The course programme is accredited by:

  • Swissethics
  • Swiss Association of Pharmaceutical Professionals (SwAPP)
  • Swiss Society of Clinical Pharmacology and Toxicology (SGKPT-SSPTC)
  • Swiss Institute for Postgraduate and Continuous Medical Education (SWIF-ISFM)

Related programme:

Liens

Renseignements / contact

Tel.: +41 (0)22 379 54 58
E-Mail: das-mas-clinical@unige.ch

orientation.ch