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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 01.07.2024

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.

Programme

9 modules

  • Principles and Methods in Clinical Research
  • Ethical and Legal Aspects
  • Preclinical Pharmacology, Toxicology and Clinical Pharmacology
  • Safety Management in Drug Development
  • Clinical Trials Set-up and Conduct
  • Clinical Trials Conduct and Close out
  • Chemistry, Manufacturing and Controls (optional)
  • Clinical Development of anti-cancer and anti infective vaccines (optional)
  • Medical Devices
  • 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

Plan de la formation

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

Admission

Conditions d’admission

Admission Criteria

  • 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 plus a minimum of 1 year professional experience in the field of the DAS
  • Good level of English (B2-C1)

The candidates who follow the programme during their working time 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

  • CHF 9'000.– for the Diploma
  • 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 delivered by the University of Geneva (33 ECTS credits).

Infos pratiques

Lieu / adresse

  • Genève (GE)

Fondation Louis Jeantet
Route de Florissant 77
1208 Genève

CMU (Centre Médical Universitaire)
Rue Michel-Servet 1
1206 Genève

Déroulement temporel

Début des cours

September.

Durée de la formation

9 modules over one year (average 24 hours of teaching per module).

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)

Liens

Renseignements / contact

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

orientation.ch