1. An agency of the European Union Presented by: David Mackay Veterinary Medicines Status update EudraVigilance Veterinary HMA-V Visegard 29 April 2011

2. 2 EudraVigilance Veterinary status update EVVet2 system (current) EVVET3 system (under development)

3. 3 3  54000 Adverse Event Reports  Maintenance mode – no major system updates  Focus on product data transfer to EVVET product dictionary EVVET2

4. 4 4

5. Access to EudraVigilance Veterinary (EVVet) 5 5 EVVET3 Business Objective: Focus EV Vet activity on product analysis instead of AE analysis Comply with new VICH / ISO/ HL7 guidelines Improve system usability and integration with other Agency systems Tracking, sharing and publishing of data analysis Simplify user management Address veterinarian’s underreporting problem Lower maintenance costs of the system Project Scope: Comply with the VICH / ISO / HL7 guidelines (subject to agreement) Integrate with EU and Agency databases namely: EUTCT; EUDRAPHARM; SIAMED and ECD (Agency users and organizations database) Easy to use online tool to replace EVWEB and avoid the need for SEF Tracking tool for data analysis and to establish analysis base-lines Simpler registration procedure Reporting tool for veterinarians Implement the Access Policy

6. 6 6 EVVET3 – 9 Business Use Cases (adopted 15 Feb VetJIG) BUCV3-03 - Define Pharmacovigilance Structure BUCV3-04 – Report Adverse Event BUCV3-05 – Process AE Report BUCV3-06 – Manage Duplicate Adverse Event Reports BUCV3-07 – Match Reported Values to Known Values BUCV3-08 – Manage Product Responsibility BUCV3-09 - Manage Product and Substance Characteristics BUCV3-10 – Manage Product Interest Data BUCV3-13 – User Account Creation

7. 7 7 EVVET3 – next (ongoing) o Development of System Use Case model o Development of System Use Cases o Discussions remain at VetJIG (PhVWP-V when necessary)

8. EVVET3 Current Plan Status Phases / MilestonesQ1 10Q2 10Q3 10Q4 10Q1 11Q2 11Q3 11 … Q4 13Q1 14 Inception End of inception Elaboration End of Elaboration Construction Today