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

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 latest terminologies; – WHO Drug Dictionary – MedDRA – WHO-ART Access to experienced co-workers at the UMC Integration with VigiSearch

10. Demonstration (static)

16. Causality Assessment

18. 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

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

20. 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

21. 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

22. A complete system!?

23. Description of software

24. Description of hardware

25. 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