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EudraVigilance



EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and also for following the marketing authorisation of medicinal products in the European Economic Area (EEA).

Additional recommended knowledge

The European EudraVigilance system deals with the:

  • Electronic exchange of Individual Case Safety Reports (ICSR, based on the ICH E2BM specifications):
    • EudraVigilance Clinical Trial Module (EVCTM) for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs).
    • EudraVigilance Post-Authorisation Module (EVPM) for post-authorisation ICSRs.
  • Early detection of possible safety signals from marketed drugs for human use.
  • Continuous monitoring and evaluation of potential safety issues in relation to reported adverse reactions.
  • Decision making process, based on a broader knowledge of the adverse reaction profile of drugs.

See also


 
This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "EudraVigilance". A list of authors is available in Wikipedia.
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