Management of Clinical Trials
DAS
Université de Genève (UNIGE)
- Ausbildungsort
-
Genf (GE)
- Unterrichtssprache
-
Englisch - Französisch
- Ausbildungstyp
-
Universitäre Hochschulen UH - Weiterbildung: Lehrgänge
- Zeitliche Beanspruchung
-
Teilzeit
- Ausbildungsthemen
-
Gesundheit, Pflege, Medizin
- Studienrichtungen
- Swissdoc
-
7.724.4.0
Aktualisiert 26.08.2019
Beschreibung
Beschreibung des Angebots
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
Voraussetzungen
Zulassung
- 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.
Kosten
CHF 7’500.-
CHF 1’500.- (individual module)
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 et processus qualité, delivered by the University of Geneva.
33 ECTS (European Credit Transfer and Accumulation System) credits.
Praktische Hinweise
Ort / Adresse
- Genf (GE)
Fondation Louis Jeantet
77 route de Florissant
1208 Genève
Zeitlicher Ablauf
Beginn
September
Dauer
1 year
Approximately 24 hours of teaching per module over one year.
Zeitliche Beanspruchung
- Teilzeit
Unterrichtssprache
- Englisch
- Französisch
Bemerkungen
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.
Links
Auskünfte / Kontakt
Tel. : +41 (0)22 372 99 34
E-mail: DAS.Clinicaltrials@hcuge.ch
Anbieter 1
Université de Genève (UNIGE)
Rue du Général-Dufour 24
1211 Genève 4
Tel.: +41 (0)22 379 71 11
URL:
www.unige.ch/
Weitere Informationen
Centre pour la formation continue et à distance (CFCD)
Université de Genève (UNIGE)
Uni Pignon
Bd de Pont-d’Arve 42
1211 Genève 4
Tel.: +41 (0)22 379 78 33
E-Mail:
URL:
www.unige.ch/formcont/