Pharmacovigilance
- UE code MSBMM216
-
Schedule
20Quarter 2
- ECTS Credits 2
-
Language
Français
- Teacher Dogne Jean-Michel
Students will be familiarized with the science and activities relating to the detection, assessement, understanding and prevention of adverse effects or any other drug related problems. The student will be familiarized with the roles and responsabilities of all stakeholders in pharmacovigilance, including regulatory bodies (i.e. EMA), pharmaceutical industries, health care professionnals, and patients. The students will also be trained with the EMA GVP modules.
The objectives are to familiarize the students with all aspects of pharmacovigilance and drug safety. A special focus will be on signal management, risk management including risk minimizations activities, risk communication and post-authorization studies.
Part 1. Basics in pharmacovigilance -Introduction
-Definition of key terms and concepts -Stakeholders in pharmacovigilance -GVP modules
-Other important guidelines
Part 2. Case discussion: students will work in two teams. Each team will prepare and present to the other team a devlopment of a specific concept of pharmacovigilance: i.e. signal detection, risk management plan.
Written exam based on a narrative of a case report (adverse events classification, PRR/ORR tabke analysis, signal managment, risk management including regulatory action and risk minimization and communication).
Training | Study programme | Block | Credits | Mandatory |
---|---|---|---|---|
Master 60 en sciences biomédicales | Standard | 0 | 2 | |
Master 120 en sciences biomédicales à finalité spécialisée en recherche préclinique | Standard | 0 | 2 | |
Master 120 en sciences biomédicales à finalité spécialisée en recherche clinique | Standard | 0 | 2 | |
Master 60 en sciences biomédicales | Standard | 1 | 2 | |
Master 120 en sciences biomédicales à finalité spécialisée en recherche préclinique | Standard | 2 | 2 | |
Master 120 en sciences biomédicales à finalité spécialisée en recherche clinique | Standard | 2 | 2 |