Pharmacovigilance
Unit 1 Notes

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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