Pharmacovigilance

Drug & Disease Classification

DRUGS ·         Any substances that, when administered via various form causes a temporary physiological and often psychological changes in the body. OR ·         A chemical substance which when administered in the living organism, produce biological effect. DISEASE ·         A particular abnormal condition that affects the structure or function of organism, and that is not due …

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ICH Guideline For Pharmacovigilance

ICH GUIDELINE FOR PHARMACOVIGILANCE Organization and objective of ICH Expedited reporting Individual case safety reports Periodic safety update reports Post approval expedited reporting Pharmacovigilance planning Good clinical practice in pharmacovigilance studies ORGANIZATION AND OBJECTIVE OF ICH   •       ICH is the international council/conference on harmonization of technical requirement for registration of pharmaceuticals for Human Use. …

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