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Integrating Knowledge into Risk-Based Decision-Making with ICH Q9(R1)
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The International Council for Harmonisation (ICH) has updated its guidelines on quality risk management (QRM) with ICH Q9(R1). This update emphasizes a more proactive and structured approach to risk management in the pharmaceutical industry, emphasizing reducing subjectivity and integrating knowledge into risk-based decision-making. The update encourages the use of digital tools and emerging technologies to control risks, and it aims to improve industry consistency and regulatory oversight. The updated guidelines promote a shift to more objective risk assessments, ultimately contributing to a safer and more reliable pharmaceutical industry by reducing quality defects and improving patient outcomes.
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