Pharmacovigilance System Master File - PSMF

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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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Course materials

GVP Module II PSMF

341 kb Download

1

Pharmacovigilance System Master File

31 Minutes

PSMF
2

Compliance - Pharmacovigilance System Documents

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9 minutes

Compliance requirements associated with the Pharmacovigilance System Documents
3

PSMF – Intro – Quiz

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6 questions
4

PSMF - Sections

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6 questions

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Pharmacovigilance System Master File - PSMF

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