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 second of these papers, proposes a practical means of monitoring and improving RBDM within the QRM process. The paper introduces the concept of Key Decision Review Points (KDRPS), which give an opportunity to reflect on the process and the outcomes of RBDM at key steps in the QRM process and thus improve the successful implementation of the subsequent steps.