This course aims to give you a large knowledge of:

• the Post-marketing Pharmacovigilance legislation in the EU e.i. the Pharmacovigilance Legal Tools, the marketing Authorisation Procedures
• an overview of the European Guideline of the good pharmacoVigilance Practices (GVP) Module I, II, III, V, VI, VII, IX and X.

At the end of this course, you will be able to know:

• the historical context of Pharmacovigilance and its need

• the legal tools for PharmacoVigilance

• marketing authorisation procedures in the European Union

• the role of European Medicines Agency

• the Guideline for good pharmacoVigilance Practices key modules covering Qualified Person responsible for PharmacoVigilance, Pharmacovigilance System Master File, inspections Risk Management Plans, spontaneous reporting, Post-Authorisation Safety Studies and Periodic Safety Update Reports