BP805E. PHARMACOVIGILANCE Books : Pharmalite.in



All books are given below after syllabus


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. 


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