EudraVigilance (EV)




EudraVigilance Database Management System (DBMS)

The EudraVigilance Database Management System (EVDBMS) is the core element of the European pharmacovigilance database. The web-based information system is designed to handle the safety report information in full compliance with the ICH specifications featuring:

  • A fully integrated organisation and user management in the EudraVigilance community synchronised with the EudraVigilance Gateway profile management,
  • A fully automated safety and message processing mechanism, using XML-based messaging, supporting both asynchronous data interchange and interactive transactions,
  • A large reference pharmacovigilance database that is built by importing and consolidating data from multiple sources, including information on medicinal products and adverse reactions,
  • Extensive query and tracking/tracing capability, both from scientific and administrative business perspectives.

The EudraVigilance Database Management System consists of two modules:

  • The EudraVigilance Clinical Trial Module (EVCTM), designed to receive ICSRs related to reports on suspected unexpected serious adverse reactions (SUSARs) that occur in the frame of interventional studies;
  • The EudraVigilance Post-Authorisation Module (EVPM), designed to receive ICSRs related to spontaneous reports and reports from non-interventional studies.
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Last update: Monday, 29 May 2006.



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