Transcription of WHO | Definitions
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WHO | Definitions
1 Definitions Pharmacovigilance adverse event adverse reaction Unexpected adverse reaction Serious adverse reaction Side effect Signal Causality2 Definitions Organisationsinvolved: WHO -World Health Organization CIOMS -Council of International Organizations of Medical Sciences ICH -International Conference on Harmonisation3 PharmacovigilanceWHO, 2002 The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug -related problem4 adverse event Medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related5 adverse reactionWHO, (1972)
adverse effects or any other drug-related problem. 4 Adverse event • Medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related. 5 Adverse reaction WHO, (1972) • 'A response to a drug which is noxious and unintended, and which occurs at
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