Improving Risk-Based Decision Making (RBDM) Effectiveness Through a Framework which Integrates Knowledge and Risk

Authors

Martin Lipa, Technological University DublinFollow
Valerie Mulholland, GMP Training & Pharmaceutical Regulatory Science Team (PRST), TU Dublin, IrelandFollow
Anne Greene (editor), Technological University DublinFollow

Abstract

This paper explores the emergence of the importance of knowledge in Risk-Based Decision Making (RBDM) and Quality Risk Management (QRM) through a detailed review of ICH Q9(R1) (Step 2) and presents a framework(the RKI cycle) to integrate knowledge and risk and associated six principles to operationalise it.

Recommended Citation

Lipa, Martin; Mulholland, Valerie; and Greene (editor), Anne (2022) "Improving Risk-Based Decision Making (RBDM) Effectiveness Through a Framework which Integrates Knowledge and Risk," Level 3: Vol. 16: Iss. 2, Article 2.
Available at: https://arrow.tudublin.ie/level3/vol16/iss2/2

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