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.

Creative Commons License

Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License
This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.



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