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Pharmacovigilance Requirements For Biological Products
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ICH guideline Q9 (R1) on quality risk management
www.ema.europa.euICH Q9(R1) Guideline 1 1 1. INTRODUCTION 2 Risk management principles are effectively utilized in many areas of business and government 3 including finance, insurance, occupational safety, public health, pharmacovigilance, and by 4 agencies regulating these industries. In the pharmaceutical sector, the principles and framework 5 of ICH Q9, coupled with the official ICH …