Transcription of Definitions - WHO
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Definitions - WHO
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)
1 Definitions • Pharmacovigilance • Adverse event • Adverse reaction – Unexpected adverse reaction – Serious adverse reaction • Side effect
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