Automated Segregation of Relevant ICSRs from EudraVigilance

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One of the key requirements of the new pharmacovigilance legislation (Regulation 726/2004) in the EU is simplified reporting of individual case safety reports (ICSRs) by a Marketing Authorization Holder (MAH) to the new EudraVigilance (EV) system. Bulk downloading of ICSRs poses a number of challenges including readability, irrelevancy, no mechanism for tracking and reconciliation, unavailability of archived cases and no quick method for distinguishing between serious and non-serious cases.

This whitepaper addresses how to overcome these challenges by automating the current manual download and review processes, and in doing so achieve efficiency gains of up to 80%. Learn about:

  • MAH challenges with the current system
  • How to achieve automation to alleviate manual processes
  • The benefits to MAHs when adopting automation tools