Syllabus Pharmacovigilance 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). (Chapter - 1) • 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. (Chapter - 2) • Basic terminologies used in pharmacovigilance : Terminologies of adverse medication related events, Regulatory terminologies. (Chapter - 3) 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. (Chapter - 4) • Drug dictionaries and coding in pharmacovigilance : WHO adverse reaction terminologies, MedDRA and Standardised MedDRA queries, WHO drug dictionary, Eudravigilance medicinal product dictionary. (Chapter - 5) • Information resources in pharmacovigilance : Basic drug information resources, Specialised resources for ADRs. (Chapter - 6) • Establishing pharmacovigilance programme : Establishing in a hospital, Establishment & operation of drug safety department in industry, Contract Research Organisations (CROs), Establishing a national programme (Chapter - 7) UNIT- III • Vaccine safety surveillance : Vaccine Pharmacovigilance, Vaccination failure, Adverse events following immunization. (Chapter - 8) • 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. (Chapter - 9) • Communication in pharmacovigilance : Effective communication in Pharmacovigilance, Communication in Drug Safety Crisis management, Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media. (Chapter - 10) UNIT-IV • Safety data generation : Pre clinical phase, Clinical phase, Post approval phase (PMS). (Chapter - 11) • 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 - 12) 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. (Chapter - 13) • CIOMS : CIOMS Working Groups, CIOMS Form. (Chapter - 14) • CDSCO (India) and Pharmacovigilance : D&C Act and Schedule Y, Differences in Indian and global pharmacovigilance requirements. (Chapter - 15)
