PHARMACOVIGILANCE BP805ET

UNIT -01

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.

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 Standardized MedDRA queries, WHO drug dictionary, EudraVigilance medicinal product dictionary.
Information resources in pharmacovigilance
Basic drug information resources, Specialized resources for ADRs.
Establishing pharmacovigilance programme
Establishing in a hospital, Establishment & operation of drug safety department in industry,
Contract Research Organizations (CROs), Establishing a national program.

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.

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

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.