Document Type

Theses, Ph.D

Rights

Available under a Creative Commons Attribution Non-Commercial Share Alike 4.0 International Licence

Disciplines

1.4 CHEMICAL SCIENCES

Publication Details

Thesis successfully submitted to Technological University Dublin in fulfilment of
the requirements for the award of Doctor of Philosophy (PhD)

Abstract

This thesis explored knowledge management effectiveness in the pharmaceutical sector and included an examination of the critical relationship between knowledge management (KM) and quality risk management (QRM) as the dual enablers of an effective pharmaceutical quality system. The primary research objectives were to improve understanding and effectiveness of the interdependency between KM and QRM and to improve knowledge management across the pharmaceutical product lifecycle, starting with a focus on knowledge transfer during technology transfer. The thesis explored how improved KM across the product lifecycle coupled with thoughtful and intentional connectivity between KM and QRM as defined by this study could lead to more informed risk-based decision making and ultimately help benefit patients.

This research study employed a variety of methods, including literature review, expert interviews, philosophical dialogue, focus groups, and case studies as a means to include a large number of stakeholders across the pharmaceutical sector. The study progress was disseminated through a variety of methods and channels including several peer-reviewed papers and conference presentations as a means to solicit input and feedback.

The research findings verify that while KM and QRM are considered highly
interdependent in theory, in practice they are – at best – partially integrated. This
suggests the industry is not leveraging the best knowledge available to inform QRM, leading to sub-optimal risk-based decision making. Furthermore, knowledge created during QRM activities may not be effectively managed.

When considering technology transfer, the study found that while knowledge transfer is considered critically important, knowledge transfer is only marginally effective for explicit knowledge and somewhat ineffective for tacit knowledge. This lack of effective knowledge transfer poses a risk to successful technology transfer and the goals of ICH Q10.

In response to these findings, the research generated a variety of outputs, many of which have already demonstrated outcomes and impacts on the sector and have the potential for seminal importance. These outputs include a Knowledge Management Process Model to define the process of knowledge management, the Risk-Knowledge Infinity Cycle (RKI Cycle) as a framework to unite KM and QRM, a framework for knowledge transfer enhancement (KTE Framework) during technology transfer, and a variety of case studies to demonstrate the impact of these outputs and their applicability across the product lifecycle.

These outputs can be immediately applied to the benefit of the pharmaceutical sector. Areas of future study include additional assets such as training and application materials to accelerate application of these outputs. Additional opportunity also exists to better define knowledge transfer toolkits, create knowledge management frameworks for other phases of the product lifecycle, and to better define the relationship between data analytics, knowledge management and risk management.

DOI

https://doi.org/10.21427/02bz-ge70

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