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EudraVigilance Services

EudraVigilance Services is the European Union’s data collection and management system for the suspected adverse reactions to medicinal products within the EEA. EudraVigilance covers the drugs that are already being marketed and the ones that are under development. It is underpinned by the XEVMPD (extended EudraVigilance Medicinal Product Dictionary). XEVMPD consists of all the details of the medical products that are licensed or under development within EEA. The EudraVigilance supports the monitoring and detection of the safety signals, it also provides the necessary tools needed to generate reports and analyse the safety data through its EudraVigilance Data Analysis System (EVDAS) interface.

IGRS will help our clients in managing all the aspects of the EudraVigilance setup, registration and user administration.

 

  • We support the ongoing electronic reporting via EVWEB reports that are generated in the E2B R2/R3 XML formats

  • Perform the regular review, and download the Individual Case Safety Reports (ICSRs) submitted to EudraVigilance.

  • Manage the article 57 (XEVMPD) database for your products including submission of development, PSMF location, authorized medicinal product (DMP/AMP) information, MAH, and QPPV contact details maintenance.

  • Monitor the EVDAS to the extent of MAH access

  • Download electronic Reaction Monitoring Reports (eRMRs)

  • Detection and evaluation of safety signals and benefit-risk analysis

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