EMEA1/CVMP2/FEDESA3/FVE4 and Veterinary Faculty of the Complutense University of Madrid
Workshop on the Veterinary Pharmacovigilance System in the EU

When:

27-28 May 2002 (afternoon jointly with HEVRA)

Where:

Spain: Madrid

Aim:

How to promote the veterinary pharmacovigilance system

PROGRAMME

Chair of the meeting
- Professor Arturo Anadon,
Head of the Department of Toxicology and Pharmacology,Complutense University,
Madrid (Spain) and President of EAVPT

DAY 1

  13.00     Registration of participants  
  13.45 Welcome Address
Prof. Dr. Manuel Rodriguez, Dean of the Veterinary Faculty		  
  14.00 - 14.20 Pharmacovigilance - Are we fulfilling our Obligations?
P. Jones, EMEA		  
  14.20 - 14.50 How does it operate in EU - Member States perspective
A. Holm, DK - G. Keck, F		  
  14.50 - 15.10 How does it operate - EMEA perspective
K. Grein, EMEA		  
  15.10 - 15.30 Industry - Report as little as possible vs what is adequate
D. Sutton, FEDESA		  
  15.30 - 15.50 Discussion  
  15.50 - 16.00 Coffee break  
  16.00 - 16.20 Does the veterinary profession support the reporting concept?
F. Nind, FVE		  
  16.20 - 16.40 The animal owner - could they care less?
P. Allen, UK		  
  16.40 - 17.00 Marketing Pharmacovigilance
T. Kamphuis, NL		  
  17.00 - 17.45 Discussion  
 

 

DAY 2
  Chair of the meeting
- representative from Authorities: C. Evans, UK
- representative from FEDESA: D. Sutton, FEDESA
  		  
  08.30 - 08.50 Role of the authorities?
C. Ibrahim, DE		  
  08.50 - 09.10 Pharmacovigilance guidelines - harmonisation let's go: VICH
D. O'Rourke, FEDESA		  
  09.10 - 09.25 Electronic reporting and the right way to present: An Introduction, incl. VEDDRA
S. Brosch, EMEA		  
  09.25 - 09.40 Chairman: Introduction to Break-out sessions  
  09.40 - 10.00 Coffee break  
  10.00 - 12.30 Breakout sessions

Workshop 1: Ideal reporting scheme 
Chair: E. De Ridder, FEDESA
Rapporteur: D. Murphy

Workshop 2: Handling of cases and analysis
Chair: B. Freischem, EMEA
Rapporteur: D. O'Rourke

Workshop 3: How can we promote pharmacovigilance?
Chair: T. Kamphuis, NL
Rapporteur: F. Nind		  
  12.30 - 14.00 Lunch  
  14.00 - 15.30 Report from each workshop session and Discussion  
  15.30 - 16.30 General Discussion and Conclusions  
  16.30 Closure of the workshop and Coffee  
       

1 EMEA European Agency for the Evaluation of Medicinal Products
2 CVMP Committee for Veterinary Medicinal Products
3 FEDESA European Federation of Animal Health
4 FVE Federation of Veterinarians of Europe

 

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