The purpose of this training is to provide you guidance described in the GVP Module III - Pharmacovigilance inspections :
On the planning, conduct, reporting and follow-up of the pharmacovigilance inspections in the EU
On the role of different parties involved
PMSF, PV Inspections Risk-based Approach, European GVP Module III
LEARNING OUTCOMES
At the end of this course, you will be able to understand the risk based approach of the PharmacoVigilance inspections and will be prepared for PV inspections from both sides as a Marketing Authorisation Holder or a PV inspector.