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GVP MODULE I - PHARMACOVIGILANCE QUALITY MANAGEMENT SYSTEM


Eu2P Short Course: GVP Module I - Pharmacovigilance Quality Management System

OBJECTIVES

The purpose of this course is to enable you:

  • to know the general philosophy of the European Guideline of the good pharmacoVigilance Practices (GVP), and
  • to better understand the new obligations of Marketing Authorisation Holder's towards the quality system of the Pharmacovigilance system(s), GVP module I .

MAH, PV Systems, European GVP Module I, Quality system, Quality system tools, Retention Periods of PV Data or Documents

 

LEARNING OUTCOMES

At the end of this course, you will be able to

  • know the definitions of the different quality system tools and retention periods of PV data/documents

  • follow the recommendations on establishment and maintenance of a quality system related to MAH PV Systems

  • comply with the overall quality objectives and guiding principles

  • adapt the quality system to the concerned organisation.

 

240 minutes
Online based learning
English language
Certificate of Achievement
400 €
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AUTHORS

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Steve Hobbiger

GlaxoSmithKline Research and Development Ltd

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Department Of Medical Pharmacology

Université de Bordeaux


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Dr. Sarah Hall

PV Director UK, Ireland, Malta and Nordics at Baxter International Inc.
Baxter International Inc.



COMPANIES OFFER

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


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