#pharmacovigilance#bpharm8thsem#bpharmpharmacovigilance#abbreviationsanddefinitionsofpharmacovigilance#basicterminologiesofpharmacovigilance
BP 805T: PHARMACOVIGILANCE (Theory)
Unit I
Introduction to Pharmacovigilance • History and development of Pharmacovigilance • Importance of safety monitoring of Medicine • WHO international drug monitoring programme • Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions • Definitions and classification of ADRs • Detection and reporting
• Methods in Causality assessment • Severity and seriousness assessment • Predictability and preventability assessment • Management of adverse drug reactions
Basic terminologies used in pharmacovigilance
Terminologies of adverse medication related events • Regulatory terminologies
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