Pharmacovigilance System Master File – PSMF

GVP Module II PSMF

File size: 341 kb

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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1
Pharmacovigilance System Master File – An Introduction
6.5 minutes

Brief overview of PSMF

2
PSMF – Intro
3 questions

1
PSMF Sections
13 Minutes

Sections of PSMF

Main Body and 9 Annexes

2
PSMF – Sections
6 questions

1
Compliance – Pharmacovigilance System Documents
9 minutes

Compliance requirements associated with the Pharmacovigilance System Documents

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Enrolled: 58 students
Duration: 60 Minutes
Lectures: 3
Level: Advanced

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