ABSTRACT
The Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has continued to progress research on quality risk management (QRM), knowledge management (KM) operational excellence (OpEx), post-approval change management (PAC, and PAC 1VQ), quality metrics and related topics covered by ICH Quality Guidelines.
Recently the focus of the PRST has been on Risk-Based Decision Making (RBDM) and as such has written a series of 4 papers on strategies to improve RBDM effectiveness. This, the first of these papers, explores the existing published research into Risk-Based Decision Making and how the topic is addressed in other high-risk industries. Learnings from this research has identified 21 essential attributes of effective RBDM, which are presented in the final section of this paper.
