B.Pharm Pharmacovigilance Notes

PHARMACOVIGILANCE UNIT-WISE NOTES – BP805ET

Unit – 1

• 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

Unit – 2

• Drug and disease classification:
• Anatomical, therapeutic and chemical classification of drugs
• International classification of diseases
• Daily defined doses
• International Non proprietary Names for drugs
• Drug dictionaries and coding in pharmacovigilance:
• WHO adverse reaction terminologies
• MedDRA and Standardised MedDRA queries
• WHO drug dictionary
• Eudravigilance medicinal product dictionary
• Information resources in pharmacovigilance:
• Basic drug information resources
• Specialised resources for ADRs
• Establishing pharmacovigilance programme:
• Establishing in a hospital
• Establishment & operation of drug safety department in industry
• Contract Research Organisations (CROs)
• Establishing a national programme

Unit – 3

• Vaccine safety surveillance:
• Vaccine Pharmacovigilance
• Vaccination failure
• Adverse events following immunization
• Pharmacovigilance methods:
• Passive surveillance – Spontaneous reports and case series
• Stimulated reporting
• Active surveillance – Sentinel sites, drug event monitoring and registries
• Comparative observational studies – Cross sectional study, case control study and cohort study
• Targeted clinical investigations
• Communication in pharmacovigilance:
• Effective communication in Pharmacovigilance
• Communication in Drug Safety Crisis management
• Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media

Unit – 4

• Safety data generation:
• Pre clinical phase
• Clinical phase
• Post approval phase (PMS)
• ICH Guidelines for Pharmacovigilance:
• Organization and objectives of ICH
• Expedited reporting
• Individual case safety reports
• Periodic safety update reports
• Post approval expedited reporting
• Pharmacovigilance planning
• Good clinical practice in pharmacovigilance studies

Unit – 5

• 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