GET CERTIFIED IN DRUG SAFETY


RECOGNIZED COURSE QUALITY


DESIGNED FOR EXPERTS BY EXPERTS


GVP MODULE VII - PERIODIC SAFETY UPDATE REPORT (PSUR)


OBJECTIVES

The objective of this training is to enable you to better understand the obligations of MAH's on Periodic Safety Update Reports so often called PSUR as described in the GVP Module VII - Rev 1.

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 €
REGISTER NOW

AUTHORS

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Dr. Sherael Webley

University of Hertfordshire

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Dr. Justina Orleans-Lindsay

Director
Acadustri Ltd


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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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+33 5 47 30 42 69

Monday-Friday / 9.00am-6.00pm CET

 

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Created By

Eu2P Partners