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Adverse reaction database

Adverse reaction database (Bivirkningsdatabase in Norwegian) is a WEB based tool developed as a part of EudraVigilance data management system.


I have been managing and participating in the development of Bivirkningsdatabase for  Statens Legemiddelverk and of the patient adverse reaction reporting  scheme: PASRAPP

“In November 2009, the EudraVigilance Expert Working Group (EV-EWG) released a revised version of the Note for Guidance Eudravigilance Human - Processing of Safety Messages and Individual Case Safety Reports applicable to all stakeholders who are exchanging ICSRs electronically in the European Economic Area (EEA) in line with the Community legislation1. The scope of this revised Note for Guidance is to improve the quality and consistency of ICSRs reported electronically to EudraVigilance. This has been achieved by strengthening the validation process of the ICH E2B(R2) data elements and by making the population of certain data elements in ICSRs mandatory…
Electronic reporting of ICSRs based on the ICH E2B(R2) standard has been implemented quite rapidly across the ICH regions. However, two major concerns have been raised during the implementation process. First, lack of mechanism in place that allows fast and efficient response to maintenance issues, and second, an increasing disharmony in the E2B(R2) data elements and their electronic transmission specifications (M2) between the regions..
In May 2005, a revised guideline for Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (E2B(R3)) was released for public consultation. In 2006, the decision was made that the ICH would pursue a new model for the development of the ICH M2 messaging standard to support the third revision of E2B…
The new final ICSR standard is to be published in January 2011.” [1]


Here are some references relevant for E2B R3:

1. Electronic management and transmission of safety data: current status and next steps,

2. Future ICSR Specification and Related Files,

3. Electronic transmission of ICSR Implementation Guide

4. Regulated product submissions

5. Backwards and Forwards Compatibilty Mapping,

6. E2B Conversion,

7. IPF: Open eHealth Integration Platform,

8. HL7 application programming interface,

9. HL7 Projects

10. Aurora HL7 Java SIG Project

11. A Java API for HL7 Version 3 RIM

12. A Software Factory Approach To HL7 Version 3 Solutions,

13. PostgreSQL Native OLEDB Provider (PGNP)

14. Microsoft, Software Factory Approach to HL7 Version 3 Solutions

15. Microsoft, HL7 v3 and BizTalkServer 2006

16. Pervasive HL7 Data Integration