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 (Chapter - 1) 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 and operation of drug safety department in industry Contract Research Organisations (CROs) Establishing a national programme (Chapter - 2) 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 (Chapter - 3) 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 (Chapter - 4) 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 CIOMS Working Groups CIOMS Form CDSCO (India) and Pharmacovigilance D&C Act and Schedule Y Differences in Indian and global pharmacovigilance requirements (Chapter - 5)