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Vigibase Online - a web-based tool for ADR management

Magnus Wallberg, M Sc Engineering Physics Helena Sjöström, Pharmaceutical officer Sten Olsson, Head, External Affairs. Vigibase Online - a web-based tool for ADR management. Content. Introduction / Background Description - flow of ADR reports Advantages I Demonstration

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Vigibase Online - a web-based tool for ADR management

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  1. Magnus Wallberg, M Sc Engineering Physics Helena Sjöström, Pharmaceutical officer Sten Olsson, Head, External Affairs Vigibase Online - a web-based tool for ADR management

  2. Content • Introduction / Background • Description - flow of ADR reports • Advantages I • Demonstration • Important features of the system • Advantages II • Future possibilities • If interest • Technical description of the system • Questions

  3. Background I • WHO report format 1981 – • NC have to comply • Lack of computer support at many NC • WHO paper forms accepted • ICH – E2B format introduced • Harmonization • Greater complexity • UMC Vigibase 2002

  4. Background II • NC choices • System based on international standard-E2b- or not • Buy commercial software • Expensive • Not directly applicable • Develop inhouse • Complicated • Time consuming

  5. Background III • SwissMedic – HIS -> HIS 2000 • Vigibase Online • Version 1.0 (2003-07-01) • No local database • Uppsala-based xml-database • Versión 2.0 (2003-11-01) • Built on E2b-standard • Text based to improve performance

  6. Vigibase Online • Fully implemented in Switzerland • Used for a year by Ghana as pilot country • Morocco latest live user • Pilot phase with Swiss company

  7. Description – flow of ADR reports

  8. Advantages I • Improvement of report quality • Mandatory fields • Possible to connect help text to each individual field • Error checks • Cut delays in ADR reporting

  9. Advantages I (contin.) • Live access to latestterminologies; • WHO Drug Dictionary • MedDRA • WHO-ART • Access to experienced co-workers at the UMC • Integration with VigiSearch

  10. Demonstration (static)

  11. Important features • Built on E2b standard • Built-in error handling/validation • adapted dependent on category of user/assessor • Download to local PC possible • Built-in support for several languages • Tools for statistics and analysis • Complete audit trail on all fields • Performance dependent on speed of internet connection

  12. Advantages II (technical aspect) • One server installation • No client installation • Unlimited numbers of users • Sharing of costs • development • maintenance

  13. How to get started • Test site (not for reporting) • Get user’s guide from the UMC • Request national data base to be established by the UMC. Provide identity of users • Users receive username & password • Free use of system for 6 months • Annual fee of USD1600 thereafter

  14. The Future • Same system for several authorities • Facilitate communication • A direct link with other system • SIGNAL document • VigiSearch • Useful (with adaptation) for other types of organizations; • Pharmaceutical companies • Simple linking to other reporting tools

  15. A complete system!?

  16. Description of software

  17. Description of hardware

  18. Thank you for your attention! Magnus.Wallberg@who-umc.org Helena.Sjostrom@who-umc.org Sten.Olsson@who-umc.org http://www.who-umc.org

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