1. Primary & secondary use of EHR systems workshop 11 & 12 October 2007 1 Focus on safety Tim Buxton Head of Sector, Project Management EMEA

2. Primary & secondary use of EHR systems workshop 11 & 12 October 2007 2 Introduction Basis of the presentation –Contribution to the discussion; not a position statement –High level, abstracted perspective Today –EudraVigilance –E2B –ISO work items: Pharmacovigilance and identification of medicinal products Interaction model –Stakeholders –Issues

3. Primary & secondary use of EHR systems workshop 11 & 12 October 2007 3 EudraVigilance E2B Message Gateway EVMPD Post CT Vet EudraVigilance Warehouse Business Intelligence ………………… Eudra- Vigilance DAS ICSR (H) ICSR (V) SUSAR

4. Primary & secondary use of EHR systems workshop 11 & 12 October 2007 4 N 547 Health informatics Identification of medicinal products Data elements and structures for the exchange of regulated product information for drug dictionaries N548 Health informatics Identification of medicinal products Structures and controlled vocabularies for pharmaceutical product identifiers (PhPIDs) N549 Health informatics Identification of medicinal products Structures and controlled vocabulary for ingredients N549 Health informatics Identification of medicinal products Structures and controlled vocabulary for ingredients N551 Health informatics Identification of medicinal products Structures and controlled vocabulary for units of measurement N551 Health informatics Identification of medicinal products Structures and controlled vocabulary for units of measurement N550 Health informatics Identification of medicinal products Structures and controlled vocabulary for units of presentation N550 Health informatics Identification of medicinal products Structures and controlled vocabulary for units of presentation N550 Health informatics Identification of medicinal products Structures and controlled vocabulary for pharmaceutical dose forms N550 Health informatics Identification of medicinal products Structures and controlled vocabulary for pharmaceutical dose forms N550 Health informatics Identification of medicinal products Structures and controlled vocabulary for routes of administration N550 Health informatics Identification of medicinal products Structures and controlled vocabulary for routes of administration N546 Health informatics Pharmacovigilance Structures and controlled vocabulary for laboratory test units for the reporting of laboratory results N546 Health informatics Pharmacovigilance Structures and controlled vocabulary for laboratory test units for the reporting of laboratory results N545 Health informatics Pharmacovigilance Individual case safety report

5. Primary & secondary use of EHR systems workshop 11 & 12 October 2007 5 An interaction model? ADR SUSAR E2B Message Signal Action Stakeholders: Patients Healthcare professionals Pharma companies Regulators IT vendors Data vendors PSUR

6. Primary & secondary use of EHR systems workshop 11 & 12 October 2007 6 Issues Reporting compliance Quality of data Consistency of data Availability of data