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3rd International Symposium on Veterinary Pharmacovigilance

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13 December 2010

Welcome Address

Dr. Helmut Tschiersky-Schöneburg
Federal Office of Consumer Protection and Food Safety, Germany

Prof. Dr. Thomas Heberer and
Dr. Cornelia Ibrahim
Federal Office of Consumer Protection and Food Safety, Germany 

Greetings and Introduction

Session 1: International Harmonisation in the Field of Pharmacovigilance

Chair: Prof. Dr. Thomas Heberer

Creating Harmony from DissonanceDr. Margarita Brown
Food and Drug Administration, Centre for Veterinary Medicine, USA
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Post Marketing Regulation of Veterinary Medicinal Products in JapanDr. Naoyuki Aihara
National Veterinary Assay Laboratory, Ministry of Agriculture, Forestry and Fisheries, Japan
Adverse Event Reporting System and a Prospect for International HarmonisationDr. Shoko Iwamoto
National Veterinary Assay Laboratory, Ministry of Agriculture, Forestry and Fisheries, Japan
International Harmonisation in the Field of Pharmacovigilance from an OIE PerspectiveDr. Elisabeth Bégon
Anses-ANMV – French Agency for Veterinary Medicinal Products, France
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Session 2: Different Approaches to Pharmacovigilance in Europe, Part 1

Chair: Dr. Cornelia Ibrahim

Pharmacovigilance in DenmarkLisbet Vesterager Borge
Danish Medicines Agency, Denmark
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The Spanish Way – Pharmacovigilance with Limited ResourcesDr. Ramiro Casimiro
Agencia Española de Medicamentos y Productos Sanitarios, Spain
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Session 3: Different Approaches to Pharmacovigilance in Europe, Part 2

Chair: Dr. Cornelia Ibrahim

Species- and Breed-Related Adverse Drug Reactions: Experience from the Swedish Veterinary Pharmacovigilance SystemDr. Hans Tjälve
Läkemedelsverket – Medical Products Agency, Sweden
Pharmacovigilance in Ireland – Case Studies from a Small Pharmacovigilance SystemLisa Woods
Irish Medicines Board, Ireland
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Session 4: Pharmacovigilance Inspections

Chair: Dr. Constance McDaniel

Veterinary Pharmacovigilance Inspections – Working together to make Pharmacovigilance more effectiveCaroline Evans
Veterinary Medicines Directorate, United Kingdom
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Pharmacovigilance Inspections....Time to Panic?Dr. Marie-Odile Hendrickx
Pfizer Animal Health, United Kingdom
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Session 5: Cooperation with Universities in the Field of Pharmacovigilance

Chair: Dr. Annette Wilke

Veterinary Pharmacovigilance Centres – the French ExperienceDr. Xavier Pineau
Veterinary Pharmacovigilance Centre of Lyon, France
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Cooperation with Universities in the Field of Pharmacovigilance – University of ZürichDr. Cedric Müntener
Swissmedic, Swiss Agency for Therapeutic Products, Switzerland
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VETIDATA – a Web based Information System on Veterinary Medicinal Products and LegislationDr. Henry Ottilie
University of Leipzig, Germany
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Cooperation with the National Pharmacovigilance Centres in GermanyDr. Jessica Stahl
University of Veterinary Medicine Hannover – Foundation, Germany
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14 December 2010

Session 6: Electronic Exchange of Pharmacovigilance Data

Chair: Dr. Anke Finnah

Centralisation of Pharmacovigilance Data in the EU, Challenges and OpportunitiesDr. Jos Olaerts
European Medicines Agency, United Kingdom
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Electronic Exchange of Pharmacovigilance Data: the Industry Journey so far and the Look ahead to the FutureSylvie Meillerais
International Federation for Animal Health Europe, Belgium
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Applying HL7 and ISO Standards to Veterinary PharmacovigilanceDr. Alan Rawling
Assured Information Systems, United Kingdom
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Session 7: Signal Detection

Chair: Dr. Annette Wilke

An Approach to Signal DetectionMichelle Nicholson
Health Canada, Canada
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Signal Generation in Veterinary Pharmacovigilance DatabasesMarietta Rottenkolber
University of Munich, Germany
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Signal Detection and Data Mining in Animal Health Pharmacovigilance from Industry PerspectiveDr. Tatty Hodge
Pfizer Animal Health, USA
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Session 8: Clinical Aspects of Pharmacovigilance

Chair: Dr. Cornelia Ibrahim

Haemorrhagic Diathesis in Calves – EpidemiologyProf. Dr. Wolfgang Klee
University of Munich, Germany
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Bovine Neonatal Pancytopenia – Regulatory Aspects of Pharmacovigilance and Update on the SituationDr. Klaus Cussler
Paul-Ehrlich-Institut, Germany
Pharmacovigilance of Bluetongue Vaccination – Experience with a Decreed Vaccination in Farm AnimalsDr. Lukas Bruckner
Institute of Virology and Immunoprophylaxis, Switzerland
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Pharmacovigilance from a Veterinary Practitioner’s Point of View – Why do we have Underreporting and how can we change this?Dr. Rainer Schneichel
Bundesverband Praktizierender Tierärzte (bpt), Germany

Session 9: Risk Management – Risk Communication

Chair: Prof. Dr. Thomas Heberer

Risk Identification and Risk Management in PharmacovigilanceDr. Kevin Woodward
AFF Woodward Consulting, United Kingdom
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Authority Perspective on Risk Management Concerning Veterinary Medicinal Products – Background, Status and ReflectionsDr. Fia Westerholm
Finnish Medicines Agency, Finland
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Exchange of Information – Established Ways and New ApproachesDr. Cornelia Ibrahim
Federal Office of Consumer Protection and Food Safety, Germany
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