GET CERTIFIED IN DRUG SAFETY


RECOGNIZED COURSE QUALITY


DESIGNED FOR EXPERTS BY EXPERTS


GVP MODULE VII - PERIODIC SAFETY UPDATE REPORT (PSUR)


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 to better understand the obligations of Marketing Authorisation Holders on Periodic Safety Update Reports (PSUR) by getting the objectives and the key concepts of the GVP Module VII.

MAH, PSUR, GVP Module VII, ICH Guidance Topic on PBRER, European Regulatory Network

 

LEARNING OUTCOMES

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

  • Understand and apply all major concepts relating to benefit risk evaluation, modular and risk based approach

  • Use the properly ad hoc template

  • Identify all the various types of Periodic Safety Updated Report assessment procedures depending on the products

  • Be aware of new changes contained in GVP Module VII - Rev1

 

180 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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