Pharmacovigilance
Unit 5 Notes

Pharmacogenomics of adverse drug reactions
Genetics related ADR with example focusing PK parameters.

Drug safety evaluation in special population
Paediatrics
Pregnancy and lactation
Geriatrics

CIOMS
CIOMS Working Groups
CIOMS Form

CDSCO (India) and Pharmacovigilance
D&C Act and Schedule Y
Differences in Indian and global pharmacovigilance requirements

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