INFO DAY ON GOOD VETERINARY PHARMACOVIGILANCE
PRACTICE AND LAUNCH OF THE GOOD PRACTICE GUIDE FOR THE ANIMAL HEALTH INDUSTRY

Wednesday 21 April 2004, Bristol Stéphanie Hotel - Avenue Louise 91-93, 1000 Brussels.

Objective: to make the relevant EU authorities aware of the responsible attitude of the animal health industry towards its obligations on pharmacovigilance via the “official” launch of its Good Veterinary Pharmacovigilance Practice Guide.

Background: the idea to elaborate a Good Veterinary Pharmacovigilance Practice Guide for the animal health industry was initiated at the joint FEDESA/EMEA/FVE workshop on Pharmacovigilance in Madrid in 2002. Industry felt that via a guide, the awareness and understanding of pharmacovigilance could be increased with the aim to demonstrate the authorities, the taking up of its responsibility in the process of pre- and post-authorisation surveillance of veterinary medicinal products.

PROGRAMME, WITH PRESENTATIONS

Welcome, E. De Ridder, Chairman of the IFAH-Europe PhV AHG

Introduction to the Good Veterinary PhV Practice Guide
B. Cornez, IFAH-Europe

EMEA/CVMP activities to promote PhV
B. Freischem, EMEA

HEVRA activities to promote PhV
G. Beechinor, HEVRA

FVE activities to promote PhV
T. Sterneberg, FVE

Discussion

Overview on other PhV activities in the EU:

Eudravigilance
B. Freischem, EMEA

Update on status of EMEA/CVMP GLs
C. Ibrahim, CVMP

Changes in the PhV provisions in the new legislation
A. Wennberg, European Commission

Discussion

Closure of the meeting

E. De Ridder, IFAH-Europe

MEETING REPORT

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