An agency of the European Union

Presented by: David MackayVeterinary Medicines

Status update EudraVigilance VeterinaryHMA-V Visegard 29 April 2011

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EudraVigilance Veterinary status update

EVVet2 system (current)

EVVET3 system (under development)

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54000 Adverse Event Reports

Maintenance mode – no major system updates

Focus on product data transfer to EVVET product dictionary

EVVET2

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EVVET2

Access to EudraVigilance Veterinary (EVVet)5 5

EVVET3Business 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

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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

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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)

EVVET3 Current Plan StatusPhases / Milestones Q1 10 Q2 10 Q3 10 Q4 10 Q1 11 Q2 11 Q3 11 … Q4 13 Q1 14

Inception

End of inception

Elaboration

End of Elaboration

Construction

Today