MSc in International Pharmaceutical Business Management

Permanent URI for this collectionhttps://dspace.griffith.ie/handle/123456789/299

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Now showing 1 - 4 of 4

Adoption and Manufacturing of Biosimilars for Autoimmune Diseases in Jordan and the Middle East: Key Barriers, Opportunities, and Global Collaboration Models
(Innopharma, 2025) Sadaa, Mohammad Abu; McMahon, Gillian
Biologic medicines have transformed the treatment of autoimmune and chronic diseases, but their development is highly complex, time-consuming, and costly. Biosimilars, offering comparable safety and efficacy at lower cost, provide an important opportunity to expand patient access, particularly in low- and middle-income countries. This study examines the barriers and opportunities for biosimilar adoption and manufacturing in Jordan and the wider Middle East, with a focus on autoimmune diseases. A mixed-methods approach was applied, combining survey data from 87 pharmaceutical, healthcare, and regulatory professionals with seven expert interviews. Analysis centred on four domains: regulation, manufacturing, market readiness, and international collaboration, benchmarked against global models. Results indicate that although Jordan has had biosimilar guidelines aligned with EMA and WHO standards since 2015, practical implementation remains limited. Local firms are mainly engaged in final product operations and analytical testing, with no upstream capacity. Key challenges include high entry costs, a shortage of specialised expertise, limited physician confidence, pricing pressures, and low public awareness. The study concludes that Jordan’s biosimilar sector is still at an early stage. Progress requires phased development, beginning with stronger regulatory practice and fill-finish partnerships, and moving towards upstream capability through education, targeted training, and collaboration between academia, industry, and international suppliers. Such a framework could position Jordan as a credible regional contributor to biosimilar development.
Electronic batch records and the process of their design and implementation within a multi-product biopharmaceutical facility in Ireland
(Innopharma, 2024) O’Driscoll, Jean; McMahon, Dr. Gillian
The dissertation relates to electronic batch records and the process of their design andimplementation within multi-product biopharmaceutical facilities. This dissertation outlines the position of electronic batch records (eBR) in the current age of digitisation within the biopharmaceutical industry. It presents the benefits that can be obtained through eBR implementation, particularly in the realm of compliance and right-first-time execution. It presents the quantity of paper record reduction within a single biopharmaceutical facility. It also outlines the challenges introduced with eBR implementation and the requirements for companies to adoptpractices and processes to realise the associated benefits. This research was focused within a single company comprising of numerous biopharmaceutical facilities on one site located in Ireland. This dissertation identified the technical hurdles that must be overcome during eBR implementation, and also the organisational barriers that could impede successful implementation. Data was collected across organisational hierarchies via an online survey (N=119). This survey aimed to collect data as it relates to (i) internal attitudes towards eBRs, (ii) eBR familiarity, (iii) ease of eBR adoption, (iv) understanding of eBR processes, (v) understanding of eBRs compared to paper records and, time/experience impact on eBR attitudes. This data was analysed to identify relationships between organisational role/functional role and the areas of investigation. Qualitative data was also collected via a series of semi-structured interviews (N=11). These interviews were completed with subject matter experts (SMEs) in eBR implementation and participants were either presently or previously involved in an eBR implementation project. They were conducted across technical and management personnel who were identified as either (1) business SMEs, experts in paper batch record content and production processes or, (2) eBR SMEs, personnel familiar with IT requirements to enable the translation of paper process to electronic. The interviews aimed to gather information across the following areas, (i) role in eBR implementation (ii)understanding of drivers for eBR implementation(iii) priority of eBR implementation within the business, (iv) challenges and benefits associated with eBR implementation, (v) structure of eBR implementation, and, (vi) behavioural and technical challenges of eBR implementation. The output from the surveys and interviews was interpreted to establish research findings associated with this dissertation. The research found that the implementation of eBRs is a complex process, and its success is not depending on a single variable. Findings showed that both technical and organisational challenges Electronic batch records and the process of their design and implementation within a multi-product biopharmaceutical facility in Ireland exist, and improvements can be made by addressing both areas. The research revealed the compliance benefits obtained through eBR implementation. It also demonstrated the significant time saving and streamlining effect of eBR in the process of batch release. However, this research also showed a need for an internal mindset change to the eBR implementation approach. It indicated a requirement for processes and practices to evolve to enable both eBR implementation and maintenance into the future. This research demonstrated the importance of understanding gaps within the current process and potential risks associated with knowledge management and training in eBRs. This dissertation’s research findings present an opportunity to adapt current approaches to eBR implementation to enable the benefits of eBR implementation within the organisation
X? An Analysis of Loopholes in the Pharmaceutical Supply Chain, and Methods for Improving Control of Counterfeit Drugs in Nigeria
(Griffith College, 2020) Yakubu, Ojima Precious
In Nigeria, the term counterfeit drug refers to drugs that have outlived their shelf life, mislabeled drugs, drugs kept under inappropriate temperatures, and drugs produced under unfavorable conditions. The supply of counterfeit drugs is an issue of great concern for the government, regulatory bodies, and industry professionals in Nigeria. Though policies and guidelines exist to control the supply, a significant amount of operating results have not been achieved yet. In Nigeria, the drug supply system needs to be carefully managed to safeguard the flow of genuine drugs throughout the supply chain. A high level of monitoring and evaluation must be enforced at all levels of the supply chain to ensure the activities of counterfeit drug peddlers are reduced as much as possible. The purpose of this research is to identify and analyze the current challenges which facilitate the loopholes in the pharmaceutical supply chain in Nigeria and propose methods that can reduce how counterfeit drugs enter the supply chain. This research aims to interact with distributors and pharmacists because they are directly involved in the supply chain and are important contact points before a drug reaches consumers. Response Rate: A total of 20 people were scheduled to be interviewed, 10 distributors, and 10 pharmacists. A total of 13 participants responded to the interview, 7 pharmacists and 6 distributors with two responding via text, recording a response rate of 65% The survey was distributed to a total of 370 participants. 70 pharmacists and 300 consumers. A total of 55 pharmacists responded to the survey and a total of 202 consumers responded to the survey giving a total of 257 responses. Hence, recording a response rate of 69.45%. The loopholes facilitating the infiltration of counterfeit drugs are that the number of unqualified workers in the supply chain is greater than the number of qualified workers, the presence of open markets, and poor implementation of laws. To control the supply of counterfeit drugs more consumer awareness needs to be done and industry experts need to familiarize themselves with more anti-counterfeit technologies and to exercise greater care in sourcing drugs.
Challenges of Logistics in India Pharmaceutical Industry
(Griffith College, 2020) Chandran, Vivek
The current research has focused on exploring the attributes and challenges that are essential in ensuing an effective logistics in Indian pharmaceutical industry. Logistics are considered as an integral part of pharmaceutical companies in India. It plays a key role in ensuring timely delivery of drugs and medical equipment. The Indian pharmaceutical industry has significant opportunity for making improvement in its products. These products are improved through deep research and various clinical trials for distributing it in the global forum. Thus, it can be stated that logistics and supply chain management systems is necessary as it will help in attracting customer loyalty in the market and building brand image. The research has undertaken a background research on the context of pharmaceutical industry in India. Data collection has also been conducted with appropriate research approaches and based on these relevant finings have been drawn. The last chapter links the objectives of the research with the finds of the research.

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