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Pharma's Well-Intentioned 'Improvements' To ICSRs Causing Problems In EudraVigilance

 
• By Vibha Sharma

EU marketing authorization holders are unknowingly duplicating individual case safety reports in the revamped EudraVigilance database, a senior regulator warns.

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Most EU Member States Have Detected Duplicates In The EudraVigilance Database • Source: Shutterstock

Drug companies using the EU’s revamped pharmacovigilance database are being told to stop submitting what they believe are "improved versions" of individual case safety reports (ICSRs) downloaded from the database if they have no new follow-up safety information from a primary source to add.

The submission of such "re-worked cases" to the EudraVigilance database is resulting in duplicates and overwhelming the new system, a senior EU regulator told delegates at a conference in London...

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