Pharmacovigilance (Theory)

Fundamentals of Pharmacovigilance a) Concept, history, and importance of pharmacovigilance b) Basic drug classification systems (introductory overview only): c) ATC classification, ICD ATC system ICD d) Drug-related problems and medication safety e) Drug safety considerations in special populations: Paediatrics Geriatrics Pregnancy and lactation

Pharmacovigilance Systems and Regulatory Framework a) Objectives and functions of pharmacovigilance b) Methods of pharmacovigilance data collection: Spontaneous reporting Cohort and case-control studies c) Global pharmacovigilance systems: WHO International Drug Monitoring Programme Role of CIOMS and major regulatory agencies (e.g., USFDA, EMA) d) Pharmacovigilance Programme of India (PvPI) e) Establishment and role of ADR Monitoring Centres

Adverse Drug Reactions (ADRs) a) Classification and types of ADRs b) Mechanisms and risk factors for ADRs c) Methods of ADR monitoring, detection, and reporting d) Assessment of causality, severity, predictability, and preventability of ADRs e) Management of ADRs f) Online reporting mechanisms and databases (WHO-ART, VigiBase, Vigiflow, Oracle Argus, OpenVigil software). g) MEDRA

Immunovigilance and Other Disciplines of Pharmacovigilance a) Definition, scope, and significance of immunovigilance, cosmetovigilance, nutraceutical-vigilance, materiovigilance, herbovigilance, ecopharmacovigilance, and hemovigilance b) Vaccination failure and vaccine pharmacovigilance (vaccinovigilance) c) Overview of adverse events following immunization (AEFIs) d) Immunization safety monitoring systems in India

Risk Communication, Evaluation, Management, and ICH Guidelines a) Risk evaluation and management strategies in pharmacovigilance and immunovigilance and immunovigilance b) Communication in drug safety crisis management c) Communication with regulatory agencies, business partners, and healthcare facilities d) Analysis of real-world case studies and lessons learnt e) Emerging trends and challenges in pharmacovigilance and immunovigilance f) Overview of safety data generation g) Objectives of ICH guidelines h) Expedited and aggregate reporting i) Individual Case Safety Reports (ICSRs) j) Periodic Safety Update Reports (PSURs) k) Post-approval expedited reporting l) Good Clinical Practices (GCPs) regulation 2019 m) Application of pharmacogenomics and pharmacometrics in pharmacovigilance.