Pharmaceutical Technology - January 2024

Pharmaceutical Technology - January 2024

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20 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com wladimir1804 - stock.adobe.com T he current International Council for Har- monisation (ICH) Q9(R1) Quality Risk Man- agement (QRM) guideline is a targeted revi- sion of the initial guidance issued in 2005, intended to address subjectivity, formality, risk- based decision-making, and other specific areas for improvement. While not a formally defined area for improvement, the revised guidance invokes many new references to "knowledge" and "knowledge man- agement (KM)" in supporting improvement in QRM practice and, by extension, to the goals of an effective pharmaceutical quality system. Recognizing that QRM and risk-based decision-mak- ing (RBDM) both depend on knowledge to be effective, it could be suggested that knowledge is the currency of managing risk. This paper presents research and perspectives on the opportunity to better connect risk and knowledge through improved integration of QRM and KM, including presenting several potential bene- fits of such integration. A framework is proposed, the Risk-Knowledge Infinity Cycle (RKI Cycle), which could be used to improve the connectivity of risk and knowledge along with preliminary and practical recommendations to operationalize the RKI Cycle. In addition, the paper Knowledge as the Currency of Managing Risk: A Smart Investment for Patients Martin J. Lipa*, PhD, martin.lipa@prst.ie, is senior research fellow, Pharmaceutical Regulatory Science Team. Anne Greene, PhD, is professor, Technological University Dublin, and director, Pharmaceutical Regulatory Science Team. *To whom all correspondences should be addressed. Editor's Note: This article was peer reviewed by a member of Pharmaceutical Technology®'s Editorial Advisory Board and was previously publised in the September 2023 issue. Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

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