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EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area (EEA).
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.
- FAQs: EudraVigilance’s EVWEB and MedDRA
- Risk Management for Medicinal Products in the EU
- Regulatory Electronic Transmission of Individual Case Safety Reports (ICSRs) in Pharmacovigilance (EMEA/H/31387/01 Final)
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