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Management of Clinical Trials

DAS

Université de Genève (UNIGE)

Kategorien
Ausbildungsort

Genf (GE)

Unterrichtssprache

Englisch

Ausbildungstyp

Universitäre Hochschulen UH - Weiterbildung: Lehrgänge

Zeitliche Beanspruchung

Teilzeit

Ausbildungsthemen

Gesundheit, Pflege, Medizin

Studienrichtungen

Humanmedizin

Swissdoc

7.724.4.0

Aktualisiert 01.07.2024

Beschreibung

Beschreibung des Angebots

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

Aufbau der Ausbildung

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

Voraussetzungen

Zulassung

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.

Kosten

  • CHF 9'000.– for the Diploma
  • 1-day module: CHF 1'000.–
  • 2-day module: CHF 1'400.–
  • 3-day module: CHF 1'800.–

Abschluss

  • 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).

Praktische Hinweise

Ort / Adresse

  • Genf (GE)

Fondation Louis Jeantet
Route de Florissant 77
1208 Genève

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

Zeitlicher Ablauf

Beginn

September.

Dauer

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

Zeitliche Beanspruchung

  • Teilzeit

Unterrichtssprache

  • Englisch

Bemerkungen

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)

Links

Auskünfte / Kontakt

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

berufsberatung.ch