GET CERTIFIED IN DRUG SAFETY


RECOGNIZED COURSE QUALITY


DESIGNED FOR EXPERTS BY EXPERTS


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


Eu2P Short Course: GVP Module VIII - Post-Autorisation Safety Studies (PASS)

OBJECTIVES

The purpose of this course is to enable you to know 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-Authorisation Safety Studies (PASS) by getting:

  •  the general framework of European regulations governing post -authorisation phase
  •  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)
  •  some inside views on the PASS implementation in industry.

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)

 

240 minutes
Online based learning
English language
Certificate of Achievement
400 €
REGISTER NOW

AUTHORS

avatar

Dr. Sherael Webley

University of Hertfordshire

avatar

Wendy Brewster

GlaxoSmithKline Research and Development Ltd


avatar

Department Of Medical Pharmacology

Université de Bordeaux



COMPANIES OFFER

Short courses can be included in a training package for your team!


NEED TO TALK TO US?

+33 5 47 30 42 69

Monday-Friday / 9.00am-6.00pm CET

 

Powered By

Eu2P Executive Board partners

Created By

Eu2P project consortium partners