Steps Beyond Risk Assessment in QRM: RBDM, The next horizon

Authors

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

Abstract

The topic of Risk-based Decision Making (RBDM) was highlighted as one of these areas requiring clarification in the International Committee on Harmonisation (ICH) concept paper for the revision of Q9. This paper examines 5 key areas on RBDM identified in the concept paper, focusing on: What good risk-based decision making actually means, How QRM may improve decision-making and How risk-based decisions might be achieved. This was executed by reviewing peer-reviewed published research literature and examining best practices in other industries, with a view to initiating a dialogue which could help advance the questions posed. Based on this analysis, a list of 21 attributes commonly applied to RBDM were identified. These criteria were sorted under the headers of Governance, Process (each QRM and KM) and People.

Recommended Citation

Mulholland, Valerie; Greene, Anne; and Lipa, Martin J. (2021) "Steps Beyond Risk Assessment in QRM: RBDM, The next horizon," Level 3: Vol. 16: Iss. 1, Article 2.
Available at: https://arrow.tudublin.ie/level3/vol16/iss1/2

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