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RECOGNIZED COURSE QUALITY


DESIGNED FOR EXPERTS BY EXPERTS


GVP MODULE VI - MANAGEMENT AND REPORTING OF ADR


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). Particularly you will better understand the new obligations of Marketing Authorisation Holder's on management and reporting of adverse reactions by getting the objectives and the key concepts of the newly revised GVP Module VI.

MAH, Risk Management System, European GVP Module VI, Reporting of ADR, Emerging Safety Issue, Post-authorisation studies

 

LEARNING OUTCOMES

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

  • Know all new definitions

  • Be able to identify and notify an emerging safety issue

  • Comply strictly with the new requirements for collecting and reporting adverse reactions in the interim and final arrangements

  • Be aware of possible new changes including in the Revision 1, particularly for the post-autorisation studies

 

120 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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