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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)

CIOMS - Council of International Organizations of Medical Sciences – ICH - International Conference on Harmonisation. 3 Pharmacovigilance WHO, 2002 • The science and activities relating to the detection, assessment, understanding …

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