Pharmacovigilance System Master File – PSMF
A Pharmacovigilance System Master File (PSMF) is a document describing the pharmacovigilance system maintained by the marketing authorisation holder (MAH) with respect to one or more authorized medicinal products.
Course Objectives:
- To get introduced to the concept of PSMF
- Learn about the various Sections of PSMF
- Learn about the Compliance requirements
To Donate: www.vigiserve.com/donate
1
Pharmacovigilance System Master File – An Introduction
Brief overview of PSMF
2
PSMF – Intro
1
PSMF Sections
Sections of PSMF
Main Body and 9 Annexes
2
PSMF – Sections
1
Compliance – Pharmacovigilance System Documents
Compliance requirements associated with the Pharmacovigilance System Documents
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