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
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).
The exact modalities of the evaluation are likely to be modified during the preparation of the examination schedules, depending on the practical constraints with which the faculty administration may be confronted, or in the event of illness / force majeure / encroachment with an internship, or because of the health situation related to the coronavirus.