ABSTRACT
This chapter reports on the findings from a recent knowledge management (KM) research study undertaken at the Irish medicines regulator to create new knowledge from the data available about sources of product quality defects and recalls in order to examine potential solutions and prevention strategies for these market-based failures. It introduces a recent Irish knowledge management research study conducted within the Irish medicines regulator, the Health Products Regulatory Authority (HPRA), which examined five years of medicinal products quality defect and recall (QDR) data, reported in the Irish market from January 2010 to December 2014. The World Health Organization (WHO) defines the term of Substandard Medicines as 'pharmaceutical products that do not meet their quality standards and specifications'. Ireland's Foreign Direct Investment Promotion Agency, IDA Ireland reports that the life sciences sector in Ireland has grown to achieve global significance from humble beginnings in the 1960s.
