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

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