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The aim of this thesis is to explore the ongoing transformation in the pharmaceutical industry and its impact on pharmaceutical quality from the perspective of risk identification. This research was built upon three key pillars: Theoretical Evidence, Operational Evidence, and Opinion-based Evidence. The regulatory environment is one of the most important external factors that affect a company’s organization, processes and technological strategy. A quantitative analysis of regulatory events since 1813 revealed that the focus of regulators from 1813 to 1970s was centred on crisis management and public health protection. Since the 1980s a gradual move towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization occurred. The evolution of the pharmaceutical transformation was assessed through systematic review of the literature. Fourteen factors were identified that impact the pharmaceutical industry in future years. These factors, termed “transformation triggers”, were considered as the theoretical evidence for the ongoing transformation. The relative importance ranking of the triggers was computed based on their prevalence within the articles studied. The four main triggers with the strongest theoretical evidence were: fully integrated pharma network, personalised medicine, translational research, and pervasive computing. Operational evidence to verify existence of the transformation triggers was compiled through systematic collection of operational data. Trends in the operational evidence and the associated theoretical evidence were compared. Strong correlation between theoretical and operational evidence was found for the four transformation triggers listed above. Key areas of contrast included; healthcare management focus, adaptive trials and regulatory enforcement where the operational evidence was stronger than the theoretical evidence. Expert opinion, obtained from a questionnaire-based survey on participants with recognised expertise in pharmaceutical regulation, product lifecycle or technology, validated the theoretical and operational evidence and supported the same four main pharmaceutical transformation triggers. A quality risk model derived from the survey indicated a firm relationship between the pharmaceutical quality risks and regulatory compliance outcomes during the marketing approval and post-marketing phases of the product lifecycle and a weaker relationship during the pre-market evaluation phase. |
