Pharmacovigilance Causality Assessment & Signal Detection: A Visual Guide

This comprehensive visual guide covers the complete landscape of pharmacovigilance causality assessment and signal detection across seven richly illustrated chapters.

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What’s Inside

Chapter 1 — Taxonomy of Drug Safety Events

The definitive classification of AE, AR, SAE, SAR, and SUSAR. Interactive hierarchy diagrams, ICH E2A seriousness criteria, and the MedDRA coding pyramid.

Chapter 2 — The Mechanics of Expectedness

Reference Safety Information hierarchy (CCSI, SmPC, USPI, IB), the expectedness decision flowchart, specificity and severity rules, and the Day 0 regulatory clock.

Chapter 3 — Causality Assessment Methodology

WHO-UMC causality categories, global introspection vs algorithmic approaches, the complete Naranjo algorithm scoring table, and the French imputability method (Dangoumau/Bégaud).

Chapter 4 — Signal Detection Frameworks

The 2×2 contingency table, PRR formula and SDR criteria, frequentist vs Bayesian approaches (BCPNN, MGPS/EBGM), limitations of spontaneous reporting, and the signal management lifecycle.

Chapter 5 — ICSR Workflows

The 4 minimum validity criteria, end-to-end case processing workflow, US safety reporting requirements, and E2B(R3) electronic transmission structure.

Chapter 6 — Quality Control System

PSMF structure and its 7 core components, QPPV personal and legal accountability, the quality cycle (Plan-Adhere-Control-Improve), audit vs inspection, and the CAPA process.

Chapter 7 — Resource Compendium

Global safety databases (VigiBase, EudraVigilance, FAERS), essential ICH guidelines (E2A through E2F), GVP modules overview, and emerging AI-powered pharmacovigilance trends.