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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.

 

30 minutes
Online based learning
English language
Certificate of Achievement
500 €
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AUTHOR

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Department Of Medical Pharmacology

Université de Bordeaux



COMPANIES OFFER

Short courses can be included in a training package for your team!


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