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GVP MODULE XVI - RISK MINIMISATION MEASURES


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 new obligations of Marketing Authorisation Holder's towards European Union Risk Management System regulation by getting the objectives and the key concepts of GVP Module XVI.

GVP Module XVI, European Union, MAH, RMS, RMP, Risk Minimisation Tools

 

LEARNING OUTCOMES

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

  • Know all major concepts/definitions

  • Understand new Risk Management System requirements

  • Use properly the ad hoc new template

  • Develop more appropriate risk minimisation tools

  • Identify which product is concerned by a Risk Management Plan, and know its major elements

 

60 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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