B.Pharm Semester 8: Pharmacovigilance notes. Pharmacovigilance examines how suspected medicine-related harms are collected, assessed and communicated. Distinguish an individual report from evidence establishing a causal relationship.
What to revise
- Reports: identify the information needed to describe a suspected adverse reaction.
- Assessment: separate signals, uncertainty and causality concepts.
- Safety systems: connect reporting pathways, data review and communication.
A quick self-check
Review a fictional adverse-event report for missing information. List what needs clarification rather than declaring the medicine caused the event.
Notes and study links
- Pharmacovigilance — B.Pharm Semester 8 notes
- Pharmacovigilance and Adverse Drug Reactions — notes PDF
- Drug Classification, Coding and Pharmacovigilance Resources — notes PDF
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