GVP Module II - Pharmacovigilance System Master File (PSMF)
OBJECTIVES
The purpose of this course is to give you knowledge and expertise of the general philosophy of the European Guideline of the good pharmacoVigilance Practices (GVP), and particularly the objectives and the key concepts of the GVP module II called Pharmacovigilane System Master File (PSMF).
European GVP Module I, PSMF, PV audits, PV Inspections, Quality System
LEARNING OUTCOMES
At the end of this course, you will be able to
describe the structure of the European Guideline of the good pharmacoVigilance Practices module
know the regulatory requirements of a Pharmacovigilance System Master File
understand the risk based approach of the PharmacoVigilance audits and inspections
know the reasons of having a product on the additional monitoring list and the related obligations.
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