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Learn how pharmacovigilance teams evaluate suspected adverse drug reactions using structured approaches, including WHO UMC causality assessment, Naranjo scale principles, and clinical evidence review. Discover how temporal relationship, dechallenge, rechallenge, and alternative causes influence safety decisions.
Understand how GVP modules shape pharmacovigilance systems, inspections, QPPV oversight, audits, risk management, and signal activities. This guide explains what regulators expect, which records matter most, and how PV teams can maintain practical, inspection-ready compliance.