This MedLibrary.org supplementary page on EudraVigilance is provided directly from the open source Wikipedia as a service to our readers. Please see the note below on authorship of this content, as well as the Wikipedia usage guidelines. To search for other content from our encyclopedia supplement, please use the form below:
Related Sponsors
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 also 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.
See also
- Pharmacovigilance
- Serious adverse event
- European Medicines Agency
- EUDRANET
- EudraCT
- EudraGMP
- EudraPharm
- Uppsala Monitoring Centre
- Yellow Card Scheme
- The International Society of Pharmacovigilance
- European Clinical Research Infrastructures Network
- Clinical trial
- Drug development
- Medication
- EudraLex
External links
- EudraVigilance
- 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)
 |
This health-related article is a stub. You can help Wikipedia by expanding it. |
Wikipedia content modification information:
- This page was last modified on 25 April 2008, at 14:04.
Wikipedia Authorship and Review
Wikipedia content provided here is not reviewed directly by MedLibrary.org. Wikipedia content is authored by an open community of volunteers and is not produced by or in any way affiliated with MedLibrary.org.
Wikipedia Usage Guidelines
This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article on "EudraVigilance".
The URL for this specific entry is:
All Wikipedia text is available under the terms of the GNU Free Documentation License. (See Copyrights for details). Wikipedia® is a registered trademark of the Wikimedia Foundation, Inc.