Pharma Frustrated With Revamped EudraVigilance Database

Pharmaceutical companies say they are wasting resources having to scan through high volumes of individual case safety reports in the revamped EU pharmacovigilance database, most of which do not relate to their products.

Stress
The revamped EudraVigilance database is causing problems for pharma • Source: Shutterstock

Drug companies have become frustrated with the newly revamped EudraVigilance database, which they claim is forcing them to waste time needlessly trawling through hundreds of individual case safety reports (ICSRs).

Since the updated database was launched last November, the number of ICSRs that companies are having to assess has increased substantially – by up to four times in some cases,...

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