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Focus on safety

Focus on safety. Tim Buxton Head of Sector, Project Management EMEA. Introduction. Basis of the presentation Contribution to the discussion; not a position statement High level, abstracted perspective Today EudraVigilance E2B

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Focus on safety

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

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

  4. 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 N 547 Health informaticsIdentification of medicinal productsData elements and structures for the exchange of regulated product information for drug dictionaries N548 Health informaticsIdentification of medicinal productsStructures and controlled vocabularies for pharmaceutical product identifiers (PhPIDs) N549 Health informaticsIdentification of medicinal productsStructures and controlled vocabulary for ingredients N550 Health informaticsIdentification of medicinal productsStructures and controlled vocabulary for pharmaceutical dose forms N550 Health informaticsIdentification of medicinal productsStructures and controlled vocabulary for units of presentation N551 Health informaticsIdentification of medicinal products Structures and controlled vocabulary for units of measurement N550 Health informaticsIdentification of medicinal productsStructures and controlled vocabulary for routes of administration Primary & secondary use of EHR systems workshop 11 & 12 October 2007

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

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

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