3rd International Symposium on Pharmacovigilance
Programme
13th December 2010
| 09:00 | Registration | |
| 10:00 | Welcome Address | Dr. Helmut Tschiersky-Schöneburg Federal Office of Consumer Protection and Food Safety, Germany |
| 10:10 | Greetings and Introduction | Prof. Dr. Thomas Heberer and Dr. Cornelia Ibrahim Federal Office of Consumer Protection and Food Safety, Germany |
| Session 1: International Harmonisation in the Field of Pharmacovigilance | ||
| 10:20 | Composing Harmony from Dissonance | Dr. Margarita Brown Food and Drug Administration, Centre for Veterinary Medicine, USA |
| 10:50 | Post Marketing Regulation of Veterinary Medicinal Products in Japan | Dr. Naoyuki Aihara
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| 11:05 | Adverse Event Reporting System and a Prospect for International Harmonisation | Dr. Shoko Iwamoto National Veterinary Assay Laboratory, Ministry of Agriculture, Forestry and Fisheries, Japan |
| 11:20 | View from an OIE Expert | Dr. Elisabeth Bégon Anses-ANMV – French Agency for Veterinary Medicinal Products, France |
| 11:40 | Discussion | |
| 11:50 | Coffee Break | |
| Session 2: Different Approaches to Pharmacovigilance in Europe, Part 1 | ||
| 12:10 | Special Impacts of the Danish Pharmacovigilance System | Lisbet Vesterager Borge Danish Medicines Agency, Denmark |
| 12:30 | The Spanish Way – Pharmacovigilance with Limited Resources | Dr. Ramiro Casimiro Agencia Española de Medicamentos y Productos Sanitarios, Spain |
| 12:50 | Discussion | |
| 13:00 | Lunch Break | |
| Session 3: Different Approaches to Pharmacovigilance in Europe, Part 2 | ||
| 14:00 | Species- and Breed-Related Adverse Drug Reactions: Experience from the Swedish Veterinary Pharmacovigilance System | Dr. Hans Tjälve Läkemedelsverket – Medical Products Agency, Sweden |
| 14:20 | Pharmacovigilance in Ireland – Case Studies from a Small Pharmacovigilance System | Lisa Woods Irish Medicines Board, Ireland |
| 14:40 | Discussion | |
| Session 4: Pharmacovigilance Inspections | ||
| 14:50 | Veterinary Pharmacovigilance Inspections – Working together to make Pharmacovigilance more effective | Caroline Evans Veterinary Medicines Directorate, United Kingdom |
| 15:20 | Pharmacovigilance Inspections....Time to Panic? | Dr. Marie-Odile Hendricks Pfizer Animal Health, United Kingdom |
| 15:50 | Discussion | |
| 16:00 | Coffee Break | |
| Session 5: Cooperation with Universities in the Field of Pharmacovigilance | ||
| 16:20 | Veterinary Pharmacovigilance Centres – the French Experience | Dr. Xavier Pineau Veterinary Pharmacovigilance Centre of Lyon, France |
| 16:40 | Cooperation with Universities in the Field of Pharmacovigilance – the Swiss Way | Dr. Cedric Müntener Swissmedic, Swiss Agency for Therapeutic Products, Switzerland |
| 17:00 | Cooperation with the University of Leipzig – VETIDATA | Dr. Henry Ottilie University of Leipzig, Germany |
| 17:20 | Cooperation with the National Pharmacovigilance Centres in Germany | Dr. Jessica Stahl University of Veterinary Medicine Hannover – Foundation, Germany |
| 17:40 | Discussion | |
| 19:30 | Dinner | |
14th December 2010
| Session 6: Electronic Exchange of Pharmacovigilance Data | |||
| 09:00 | Centralisation of Pharmacovigilance Data in the EU, Challenges and Opportunities | Dr. Jos Olaerts European Medicines Agency, United Kingdom | |
| 09:30 | Electronic Exchange of Pharmacovigilance Data: the Industry Journey so far and the Look ahead to the Future | Sylvie Meillerais International Federation for Animal Health Europe, Belgium | |
| 10:00 | Applying HL7 and ISO Standards to Veterinary Pharmacovigilance | Dr. Alan Rawling
| |
| 10:30 | Discussion | ||
| 10:40 | Coffee Break | ||
| Session 7: Signal Detection | |||
| 11:10 | An Approach to Signal Detection | Michelle Nicholson Health Canada, Canada | |
| 11:30 | Signal Generation in Veterinary Pharmacovigilance Databases | Marietta Rottenkolber University of Munich, Germany | |
| 12:00 | Signal Detection and Data Mining in Animal Health Pharmacovigilance from Industry Perspective | Dr. Tatty Hodge Pfizer Animal Health, USA | |
| 12:30 | Discussion | ||
| 12:40 | Lunch Break | ||
| Session 8: Clinical Aspects of Pharmacovigilance | |||
| 13:40 | Epidemiological Aspects of Bovine Neonatal Pancytopenia | Prof. Dr. Wolfgang Klee University of Munich, Germany | |
| 14:00 | Haemorrhagic Diathesis in Calves – Regulatory Aspects | Dr. Klaus Cussler Paul-Ehrlich-Institut, Germany | |
| 14:20 | Pharmacovigilance of Bluetongue Vaccination – Experience with a Decreed Vaccination in Farm Animals | Dr. Lukas Bruckner Institute of Virology and Immunoprophylaxis, Switzerland | |
| 14:40 | 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 | |
| 15:00 | Discussion | ||
| 15:10 | Coffee Break | ||
| Session 9: Risk Management – Risk Communication | |||
| 15:30 | Risk Identification and Risk Management in Pharmacovigilance | Dr. Kevin Woodward AFF Woodward Consulting, United Kingdom | |
| 16:00 | Authority Perspective on Risk Management Concerning Veterinary Medicinal Products - Background, Status and Reflections | Dr. Fia Westerholm Finnish Medicines Agency, Finland | |
| 16:30 | Exchange of Information – Established Ways and New Approaches | Dr. Cornelia Ibrahim Federal Office of Consumer Protection and Food Safety, Germany | |
| 16:50 | Discussion and Closing Remarks | ||