Learning outcomes

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.

Goals

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.

Content

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.

Teaching methods

Lecture with active participation of the students based on recent real life cases.

Assessment method

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).

 

Language of instruction

English