EudraVigilance
Encyclopedia
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 for following the marketing authorisation of medicinal products in the European Economic Area
(EEA).
The European EudraVigilance system deals with the:
Adverse event
An adverse event 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 treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...
during the development of new drugs
Drug
A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
and for following the marketing authorisation of medicinal products in the European Economic Area
European Economic Area
The European Economic Area was established on 1 January 1994 following an agreement between the member states of the European Free Trade Association and the European Community, later the European Union . Specifically, it allows Iceland, Liechtenstein and Norway to participate in the EU's Internal...
(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 (SUSARSerious adverse eventA serious adverse event in human drug trials are defined as any untowardmedical occurrence that at any dose#results in death,#is life-threatening#requires inpatient hospitalization or prolongation of existing hospitalization...
s). - EudraVigilance Post-Authorisation Module (EVPM) for post-authorisation ICSRs.
- EudraVigilance Clinical Trial Module (EVCTM) for reporting Suspected Unexpected Serious Adverse Reactions (SUSAR
- 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
- PharmacovigilancePharmacovigilancePharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
- Serious adverse eventSerious adverse eventA serious adverse event in human drug trials are defined as any untowardmedical occurrence that at any dose#results in death,#is life-threatening#requires inpatient hospitalization or prolongation of existing hospitalization...
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
- EUDRANETEUDRANETEUDRANET, the European Telecommunication Network in Pharmaceuticals , is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and evaluation of applications...
- EudraCTEudraCTEudraCT is the European Clinical Trials Database of all clinical trials commencing in the European Union from 1 May 2004 onwards...
- EudraGMPEudraGMPEudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators...
- EudraPharmEudraPharmEudraPharm is the database of medicinal products authorised in the European Union, and includes the information contained in the Summary of Product Characteristics, the patient or user package leaflet and the information shown on the labelling...
- Uppsala Monitoring CentreUppsala Monitoring CentreThe Uppsala Monitoring Centre , located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring...
- Yellow Card SchemeYellow Card SchemeThe Yellow Card Scheme is the UK system for collecting information on suspected Adverse Drug Reactions to medicines. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Dr Bill Inman....
- The International Society of PharmacovigilanceThe International Society of PharmacovigilanceThe International Society of Pharmacovigilance , previously the European Society of Pharmacovigilance , is an international non-profit scientific organisation, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of...
- European Clinical Research Infrastructures Network
- Clinical trialClinical trialClinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
- Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
- MedicationMedicationA pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
- EudraLexEudraLexEudraLex is the collection of rules and regulations governing medicinal products in the European Union.-Volumes:EudraLex consists of 10 volumes:*Concerning Medicinal Products for Human use:**Volume 1 - Pharmaceutical Legislation....