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). An adverse event (AE is any adverse change in health or "side-effect" that occurs in a person who participates in a Clinical trial while the patient is receiving the A drug, broadly speaking is any chemical substance that when absorbed into the body The European Economic Area ( EEA) came into being on 1 January 1994 following an agreement between member states of European Free Trade Association (EFTAthe

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). The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH is a project that brings together the regulatory authorities A serious Adverse event (SAE in human Drug trials are defined as any untowardmedical occurrence that at any dose results in death is Life-threatening
  • 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)

Pharmacovigilance (PV is the pharmacological Science relating to the detection assessment understanding and prevention of adverse effects, particularly A serious Adverse event (SAE in human Drug trials are defined as any untowardmedical occurrence that at any dose results in death is Life-threatening The European Medicines Agency ( EMEA) is a European agency for the evaluation of medicinal products. EUDRANET, the European Telecommunication Network in Pharmaceuticals ( E uropean U nion D rug R egulating A uthorities Net EudraCT ( E uropean U nion D rug R egulating A uthorities C linical T rials is the European Clinical Trials Database EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. EudraPharm ( E uropean U nion D rug R egulating A uthorities Pharm aceutical Database is the database of medicinal products authorised The Uppsala Monitoring Centre (the UMC located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International This article is about Human Medicines For Veterinary Medicines see the Suspected Adverse Reaction Surveillance Scheme. The International Society of Pharmacovigilance (ISoP previously the European Society of Pharmacovigilance (ESOP is an international non-profit scientific organisation which aims to The European Clinical Research Infrastructures Network (ECRIN was established in 2004 with funding from Sixth Framework Programme as a reciprocal knowledge programme In health care clinical trials are conducted to allow safety and Efficacy data to be collected for new drugs or devices Drug development or preclinical development is defined in many pharmaceutical companies as the process of taking a new chemical lead through the stages necessary to allow it Medication, also referred to as medicine, can be loosely defined as any substance intended for use in the diagnosis cure mitigation treatment or prevention of disease EudraLex is the collection of rules and regulations governing medicinal products in the European Union.

---

© 2009 citizendia.org; parts available under the terms of GNU Free Documentation License, from http://en.wikipedia.org
Dapyx Software network: MP3 Explorer | Ebook Manager | Zenithic