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GVP MODULE VIII - POST-AUTORISATION SAFETY STUDIES (PASS)


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 Holders related to Post-Autorisation Safety Studies (PASS) by getting the objectives and the key concepts of the GVP Module VIII alone, plus Addendum I (Member States' requirements for transmission of information on non-interventional post-authorisation safety studies).

MAH, GVP Module VIII, PASS, PV, PRAC, Evaluation of the risks, risk minimisation activity

 

LEARNING OUTCOMES

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

  • Know all major concepts/definitions

  • Follow strictly the recommendations related to the content of study protocol, abstract and study reports for non-interventional Post-Autorisation Safety Studies imposed as a condition to the marketing authorisation

  • Know the reasons for imposing Post-Autorisation Safety Studies and the role of Pharmacovigilance and Risk Assessment Committee (PRAC)

 

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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