ItemFactors that Affect the Implementation of Good Distribution Practices: A Comparative Analysis of Indigenous Pharmaceutical Companies in Nigeria and Ireland(2023-08) Chisom John, AnaeduThis study investigates the variables affecting indigenous pharmaceutical firms' (IPC) adoption of Good Distribution Practices (GDP) in Nigeria and Ireland. The study sheds light on the opportunities and problems related to GDP implementation by contrasting the viewpoints of experts with expertise in these two very different situations. There were 92 responses to the online survey questions (82) and phone interviews (10) used to collect the data. According to the report, both Nigeria and Ireland confront problems with their infrastructure, finance, and regulatory frameworks that make it difficult for local pharmaceutical companies to apply GDP recommendations effectively. Notably, the study discovered that while both countries face comparable issues, subtle differences in the scope and character of those challenges are introduced by the distinctive developmental landscapes of Nigeria and Ireland. The study stressed the role that legal frameworks have in encouraging GDP compliance and identified that regulatory inconsistency and gaps could cause implementation difficulties in both nations. This emphasises the significance of collaboration across regulatory organisations, such as Nigeria's NAFDAC and Ireland's HPRA, to harmonise methods to foster the adoption of more efficient guidelines. The study also demonstrated the crucial part that training and education play in establishing workforce competency and awareness of GDP requirements. Among the information gathered were suggestions for improving GDP implementation by resolving the identified difficulties hindering the implementation of Good Distribution Practices by indigenous pharmaceutical companies. ItemContract research organizations for outsourcing pharmaceutical research in Ireland: an industrial insight(2023-08) Padmanabhan Nair, AparnaThis study analysed the evolving landscape of pharmaceutical research outsourcing, with a specific focus on contract research organizations (CROs) in Ireland. By investigating the motivations, factors, challenges, and implications of pharmaceutical research outsourcing, this study contributes to an understanding of outsourcing practice within the Irish pharmaceutical industry. The research objectives consisted of exploring the drivers for outsourcing, identifying commonly outsourced research areas, investigating the criteria for selecting CRO partners, and examining challenges and future directions. The research methodology adopted was qualitative research, wherein semi-structured interviews with professionals directly involved in decision-making processes within pharmaceutical companies based in Ireland were conducted over zoom calls. Thematic analysis was employed, unveiling significant themes such as motivations for outsourcing, commonly outsourced areas, key factors in CRO selection, challenges, and emerging trends. Findings indicated that while cost reduction is a driving factor, smaller pharmaceutical firms are motivated by budget constraints. Pharmacovigilance and clinical trials were most commonly outsourced areas according to the interviewees. Collaborative abilities and expertise emerged as pivotal with respect to CRO selection criteria. Challenges included staying updated with regulatory guidelines and managing staff turnover in outsourced projects. The study also helps to forecast future trends, highlighting the growing need for management-based expertise within the pharmaceutical industry. This research provides insights for stakeholders in the Irish pharmaceutical landscape, both contract research organizations and pharmaceutical firms, encouraging collaboration, addressing skill gaps, and optimizing outsourcing strategies. Furthermore, it culminates in the realization that industry's dynamics are dependent on the constituting it. ItemThe impact of serialisation on operational efficiency and productivity in Irish pharmaceutical sites(2020) O'Mahony, DanielSerialisation technology was introduced to protect the pharmaceutical supply chain from infiltration by falsified and substandard medicines. The implementation of serialisation systems required a substantial investment by pharmaceutical manufacturers. This study investigated the impact of serialisation on the operational efficiency and productivity in Irish pharmaceutical sites. Ireland plays an important role in the global pharmaceutical manufacturing network. All of the top ten largest pharmaceutical companies have manufacturing operations in Ireland. A review of the literature showed only limited publications on the topic of serialisation, operational efficiency, and productivity, particularly in the Irish context. A research method was designed to assess the relationship between serialisation, operational efficiency, and productivity. The research consisted of a survey and interview process with 11 manufacturing sites in Ireland. Participating companies operated a total of 114 pack-lines, representing approximately 65% of the automated packing lines in the country. The research focused on measurements such operational equipment effectiveness (OEE), line availability, unit cost and cost per pack. The study revealed that serialisation had a negative impact on pack line OEE and line availability. The research found that serialisation had a negative impact on the unit cost of packaged pharmaceuticals. The study assessed the expected costs of serialisation with the actual costs experienced by manufacturers. The research found that the actual capital costs of serialisation were four times greater than the costs originally outlined by policymakers. The study identified a trend where Irish pharmaceutical sites are moving away smaller batch production and moving toward larger batches so as to gain greater efficiencies, The research also proposed the use of a serialisation depreciation factor ( 𝑆𝐷𝑓) as a method to determine the impact of serialisation on the cost of goods sold. ItemThe Impact of Blockchain Technology on Clinical Trial Data Integrity(2020) Cullen, KarlIn this study it was shown how a new and emerging technology known as Blockchain, a data management platform, possesses the potential to address some of the predominant issues pertaining to clinical data integrity within clinical trial research studies. However, many obstacles and challenges persist with its implementation and these must be addressed, understood and solved before the technology can be utilized to manage clinical data. The main research objective of this study was to examine how Blockchain could be suited to address the concerns relating to clinical data integrity and to address the perceptions of participants involved with clinical data management to the technology and its potential application within clinical trials. Through an exploratory quantitative and qualitative mixed methods approach aligned with a pragmatist research philosophy, primary data was collected from participants who were purposively selected from a homogenous sampling pool that consisted of those with backgrounds in clinical data management. Primary data produced from this study highlighted the correlation of data issues that contribute towards the lack of integrity of clinical data with those found in secondary research. It was also found that the perception of Blockchain was generally positive and favorable towards its adoption within clinical trials. However, there was a degree of uncertainty surrounding the security of data within Blockchain. Various challenges were identified, primarily, the complexity of the technology and challenges related to compliancy with data protection laws. The conclusive determination of Blockchain’s suitability to address clinical data concerns, however, remains unanswered and further research is needed to test the application of Blockchain in real-world clinical trial environments. Further research and studies are also necessary to address the many challenges that face Blockchains implementation with clinical data management. ItemAn Analysis of The Use of Wearable Technology as A Means of Controlling Drug Delivery Systems and The Challenges Facing Its Usage in Ireland(2020) Adewumi, Bolatito TemitayoIn this study, the possible/existing use (in Ireland) of wearables (such as the smartwatches, patches, and contact lenses) in controlling drug delivery systems (such as pumps and nanoparticles) was analysed. The challenges affecting the use of this technology in Ireland were determined. The public and potential customers' perception of the novel technology was examined along with how the creation will be potentially received in the market. Ireland was the country of choice because the researcher resides there and because of the heavy presence of many pharmaceutical companies in the country. The secondary research was conducted by looking into the concept of controlled drug delivery and how it works. The history, uses and the market for wearable devices was explored globally and in Ireland. The concept of wearable device-controlled drug delivery systems was then introduced. The different commercially available ones were analysed and the challenges facing the use were examined. The data collection involved quantitative research via questionnaire (219 participants) to establish the challenges facing the development and manufacture of this type of drug delivery system. The knowledge and views of Irish consumers concerning the use of this technology were established. Qualitative data was also collected via interviews (of 3 industry experts) to further explain these technologies and determine the level of progress in the research & development and manufacture of the devices in Ireland. The use of wearable devices in controlling drug delivery systems is still at its early stage in Ireland and some people have little or no knowledge of the use of this type of drug delivery system. Majority of the participants were interested in using the technology (83.5%), 65.6% would rather use this wearable device-controlled drug delivery system because more than half of the participants trust that this type of drug delivery system is more effective. Some of the limitations of the use of this type of drug delivery system from the consumers’ point of view are based on the concerns on the high cost, efficiency, and accuracy of this type of drug delivery system. The size, look, comfort, and ease of use of these devices influence the use of this type of drug delivery system. According to the industry experts, challenges like heavy regulations and the massive amount of time, money, and resources involved in the Research & Development affect the manufacture and use of wearable device-controlled drug delivery systems in Ireland.