Pharmacovigilance Free Notes Download – B. Pharm

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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Unit II

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


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Unit III

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

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Unit IV

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

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Unit V

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 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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