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GVP MODULE VI - COLLECTION, MANAGEMENT AND SUBMISSION OF REPORTS OF SUSPECTED ADR TO MEDICINAL PRODUCTS


OBJECTIVES

The purpose of this training is to enable you to better understand the new obligations of Marketing Authorisation Holder's (MAH's) on collection, management and submission of reports of suspected Adverse Reactions to Medicinal Products as described in GVP Module VI rev. 2 effective since 22nd of November 2017.

 

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

 

LEARNING OUTCOMES

Once completed, you will be able to:

  •  Know all new definitions

  •  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 new changes including in the Revision 2, particularly for the ICSRs

 

240 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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