EudraVigilance
EudraVigilance
EudraVigilance (pronounced: yoo-dra-vij-uh-luhns) is a system designed for the collection, management, and analysis of reports of suspected adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA).
Etymology
The term "EudraVigilance" is a portmanteau of two words: "Eudra", which is an acronym for European Union Drug Regulatory Authorities, and "Vigilance", which refers to the act or state of keeping careful watch for possible danger or difficulties.
Function
EudraVigilance is a key tool in the European Medicines Agency's activities to protect public health. It supports the agency's main task of overseeing the safety of medicines across Europe by providing a set of technical tools and procedures for managing data on the safety of authorised medicines.
Related Terms
- Pharmacovigilance: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
- Adverse Drug Reaction (ADR): A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.
- European Medicines Agency (EMA): A decentralised agency of the European Union (EU) in charge of the scientific evaluation, supervision and safety monitoring of medicines in the EU.
See Also
External links
- Medical encyclopedia article on EudraVigilance
- Wikipedia's article - EudraVigilance
This WikiMD dictionary article is a stub. You can help make it a full article.
Languages: - East Asian
中文,
日本,
한국어,
South Asian
हिन्दी,
Urdu,
বাংলা,
తెలుగు,
தமிழ்,
ಕನ್ನಡ,
Southeast Asian
Indonesian,
Vietnamese,
Thai,
မြန်မာဘာသာ,
European
español,
Deutsch,
français,
русский,
português do Brasil,
Italian,
polski