Mastering the ICSR

Every adverse event report that reaches a drug safety department becomes an Individual Case Safety Report (ICSR) - and the quality of that case determines whether real safety signals are detected, assessed, and acted on. Mastering the ICSR: Case Processing in Modern Pharmacovigilance is a practical, end-to-end guide to how ICSRs are received, assessed, coded, written, and reported to regulators. Written by Dr. Hafez Selim, MD, PhD, a pharmacovigilance physician with long experience in drug and medical device safety, the book walks through the full case lifecycle: - Case intake, triage, and the four minimum criteria for a valid case - Seriousness, expectedness, and causality assessment - MedDRA coding of adverse events, medical history, and indications - Writing clear, complete, medically sound case narratives - Follow-up, duplicate detection, and data reconciliation - Expedited and periodic reporting timelines and E2B(R3) electronic submission - Quality control and compliance in case processing Worked examples, checklists, and visual aids help readers apply each step in daily work. Whether you are new to drug safety, preparing for a case processing role, or an experienced professional looking for a structured reference, this book will help you produce accurate, compliant, and medically meaningful ICSRs.