Etudes cliniques, pharmacovigilance et risques médicamenteux

whopi2110  2022-2023  Bruxelles Woluwe

Etudes cliniques, pharmacovigilance et risques médicamenteux
4.00 credits
25.0 h + 5.0 h
Q2
Teacher(s)
Halleux Séverine; Hamdani Jamila; Hardt Karin; Henrard Séverine (coordinator); Ngougni Pokem Perrin (compensates Henrard Séverine);
Language
French
Content
At the end of the course, the student will be able to:
- Understand the historical, scientific, statistical, legislative and ethical aspects of clinical studies in the context of drug development.
- To know the different participants in a clinical study and the implementation of a clinical trial in a hospital pharmacy in particular.
- Understand and analyse the safety of drugs in the context of an overall benefit/risk assessment.
- Understand the basic principles of pharmacovigilance and its methods (adverse event reporting, signal detection, signal evaluation, decision making, communication) and describe the different possibilities of risk minimisation activities.
Teaching methods
The course will be given in the form of lectures illustrated by concrete examples
Evaluation methods
Oral examination. The final mark is the arithmetic average of the marks for the clinical studies part, which is worth 10/20, and the pharmacovigilance and drug risks part, which is worth 10/20
Other information
This course is intended for students who have a thorough knowledge of pharmacy (e.g. students who have a bachelor or master degree in pharmaceutical sciences).
Teaching materials
  • Supports de cours sur Moodle (diapositives,..)
Faculty or entity
FARM


Programmes / formations proposant cette unité d'enseignement (UE)

Title of the programme
Sigle
Credits
Prerequisites
Learning outcomes
Advanced Master in Hospital Pharmacy