WHO | Definitions
[Pages:16]Definitions
? Pharmacovigilance
? Adverse event
? Adverse reaction
? Unexpected adverse reaction
? Serious adverse reaction
? Side effect
? Signal
? Causality
1
Definitions
? Organisations involved:
? WHO - World Health Organization ? CIOMS - Council of International
Organizations of Medical Sciences ? ICH - International Conference on
Harmonisation
2
Pharmacovigilance
WHO, 2002
? The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drugrelated problem
3
Adverse event
? Medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related
4
Adverse reaction
WHO, (1972)
? '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 modifications of physiological function'.
5
Unexpected adverse reaction
? Not consistent with applicable product information or characteristics of drug.
6
Side effect
? Unintended effect occurring at normal dose related to the pharmacological properties
7
Signal
? Possible causal relationship adverse event and drug
? Previously unknown or incompletely documented
? More than one report is needed. Depending on:
? Quality of the information ? Seriousness of the event
8
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related download
- pharmacovigilance glossary section 1
- common terminology criteria for adverse events v3 0 ctcae
- adverse drug reactions accp
- who definitions
- adverse drug events adverse drug reactions
- fips 199 standards for security categorization of federal
- adverse effect training materials
- adverse event outcome report nahc
- template for reporting adverse events
- glossary and definitions of terms used in ghtf documents
Related searches
- philosophy definitions and terms
- word definitions synonyms and antonyms
- synonyms and definitions of words
- definitions of marketing
- definitions of philosophy by philosophers
- definitions of quality
- vocabulary words and definitions worksh
- adjectives definitions and lists
- history definitions and terms
- vocabulary words and definitions printable
- why are definitions important
- definitions and sentences dictionary