The 4th Annual TOPRA Veterinary Symposium

Regulators and industry - some common approaches to improving the regulatory environment

TOPRA in Stockholm: Symposium Preview

Come and hear all the latest Regulatory legislation and guideline proposals from the Regulatory agencies and industry. You will be able to have an update on such Regulatory activities such as electronic submissions, Variations, CMDv Work Programme, HMA activities and ongoing and proposed changes in Veterinary legislation and guidelines.

2009 will see TOPRA's 4th Annual Veterinary Symposium. Previous Symposia were held in Amsterdam, Copenhagen and Budapest. Building relationships is an important part of the TOPRA Symposium and this year we welcome the Medicines Product Agency, Sweden, who will be assisting with the organisation of the programme. This meeting will be an ideal opportunity to get to know this important agency better, as well as to network with key regulatory professionals in the Veterinary Medicines field.

Why attend the TOPRA Veterinary Symposium?

• Hear the latest regulatory intelligence on key issues in Regulatory Affairs from our international speaker panel.
• Collect new ideas to help you and your business meet the challenges and maximise the opportunities offered by the current regulatory environment.
• Maintain and develop your network of industry and agency contacts.

Working party and speakers

• Ray Harding, (Chair of Vet Symposium working party), Cyton Biosciences Ltd
• Rick Clayton, IFAH-Europe
• Mária Szabó, Central Agriculture Office, Directorate of Veterinary Medicinal Products, Hungary
• Guilluame Agède, Céva Santé Animale, France
• Henrik Holst, MPA, Sweden
• Patrick Dehaumont, Agence Nationale du Médicament Vétérinaire (ANMV), France
• Fredrik Hultén, MPA, Sweden
• Karolina Törneke, MPA, Sweden
• Per Helboe, Danish Medicines Agency, Denmark
• Esther Werner, Paul-Ehrlich-Institut, Germany
• Christophe Debruyne, Federal Agency for Medicines and Health Products, Belgium
• Veena Singh, Pfi zer Animal Health, UK
• Melanie Leivers, Veterinary Marketing Authorisation Procedures, EMEA
• Sylvie Meillerais, IFAH Europe

Programme Includes

Session I: Keynote presentations on the opportunities for re-organisation of the regulation of veterinary medicines in Europe

• “Opportunities for improving legislation” HMA Reflection Paper: Progress since 2008
• Review of Veterinary Legislation in 2010, Impact Analysis in 2009
• Progress on HMA Strategy for an efficient European Medicines Regulatory Network

Session II: Outcomes of recent joint focus group meetings and joint workshops

• CVMP Oncology Guideline
• CVMP Bioequivalence Guideline
• Electronic Submissions
• Antimicrobial Resistance - report of the joint HMA/EMEA workshop

Session III: CMDv initiatives - bringing efficiencies to the system

• CMDv Work Programme
• Labelling Initiative; one year on?

Session IV: Better regulation - bringing efficiencies to the system

• Variations: making the system work?
• Pharmacovigilance update
• IFAH-Europe proposals for review of PV Chapter in 2010

Read about last year's TOPRA Annual Veterinary Symposium 2008