MSc in Pharmaceutical Business and Technology

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Investigating Sustainability and Waste Management in Blister Packaging: A Comparative Study of Global Production Sites in a Pharmaceutical Manufacturing Company.
(Innopharma, 2025) Black, Charlotte; Regan, Regina
Blister packaging is the predominant format for oral solid-dose pharmaceutical products, valued for its protection and compliance benefits; however, its complex construction utilising multiple materials (PVC, PVDC, aluminium) renders most blister waste non-recyclable and harmful to the environment. A review of existing literature demonstrated detailed analyses of material properties and laboratory-scale separation techniques, but revealed four critical gaps: (1) a lack of site-level data on actual blister waste volumes and disposal methods; (2) limited evaluation of recycling technologies under real-world, GMP-compliant conditions; (3) insufficient insight into how regulatory frameworks (e.g., the EU Green Deal) translate into operational practice; and (4) minimal incorporation of packaging experts’ perspectives on barriers and enablers for sustainable change. To address these gaps, this study employed a mixed-method design, conducting an online survey of 30 subject-matter experts across 17 global blister-production sites. Quantitative questions captured annual waste tonnages (90–148,000 kg per site), waste-stream distributions (incineration most prevalent, recycling less common), and material selection drivers (performance rated highest,sustainability ranked lowest). Qualitative responses explored trial outcomes for sustainable alternatives, revealing that 88% of sites had conducted trials but only 11% achieved successful implementation, with performance concerns, lack of suitable alternatives, and high cost cited as primary barriers. The findings underscore the necessity of strengthening supplier partnerships to enhance alternative material robustness, expanding regulatory engagement to clarify recyclability requirements, and implementing systematic waste-monitoring frameworks to benchmark progress. By using these insights to construct an actionable plan, the pharmaceutical sector can take a crucial first step towards mitigating the environmental impact of blister packaging and fostering long-term sustainability in its global manufacturing network.
Assessing the Efficacy of Process Analytical Technology (Pat) in Detecting Out-of-Specification (Oos) Results During Pharmaceutical Manufacturing
(Innopharma, 2025) Saji, Sinci; O’ Driscoll, Mary
In this study, it was shown that Process Analytical Technology (PAT) is an effective tool in improving product quality and reducing Out-of-Specification (OOS) results during pharmaceutical manufacturing in India. The research aimed to evaluate the adoption and challenges of PAT, with a focus on its role in detecting Out of Specification results, process deviations and monitoring Critical Quality Attributes (CQAs) in real-time. A survey of 123 experienced professionals from various sectors of the Indian pharmaceutical industry was conducted and Quantitatively analysed to assess the effectiveness, barriers, and opportunities for PAT implementation. The results revealed the PAT’s ability to detect OOS results and improve process control compared to conventional methods. PAT also helped to identify CQAs accurately, thus allowing early interventions and minimizing potential product recalls. Despite the overwhelming recognition of PAT’s benefits, several challenges were identified that impede its full adoption. These includes Technical Barriers, Resource related barriers, Regulatory Challenges as well as Organisational Barriers The study concludes that while PAT is highly regarded for its ability to enhance product quality and manufacturing efficiency by the real time monitoring of OOS results and process deviations, its widespread adoption in the Indian pharmaceutical industry is hindered by technical, financial, regulatory, and organizational challenges. To address these issues, the study recommends the implementation of regular and up to date training programs, development of cross-functional PAT teams, and stronger engagement with regulatory bodies to simplify approval processes. The findings also suggest that academic institutions should incorporate PAT into curricula to build a skilled workforce capable of supporting its integration into industry practices. These findings provide valuable insights for industry practitioners, policymakers, and educators aiming to foster more effective use of PAT in pharmaceutical manufacturing, ultimately contributing to improved operational excellence and product quality in the sector.
Evaluating the Role of Process Analytical Technology (PAT) in Enhancing Pharmaceutical Manufacturing Efficiency in India
(Innopharma, 2025) Rajesh, Amal Surya Puthur; Chiedozie, Chiamaka
This study investigates the impact of Process Analytical Technology (PAT) on manufacturing efficiency, product quality, regulatory compliance, and cost-effectiveness in the Indian pharmaceutical industry. PAT, an advanced technology framework introduced by the U.S. Food and Drug Administration (FDA), enables real-time monitoring and control of critical process parameters during pharmaceutical production. The research aims to assess the key drivers and barriers to PAT adoption, evaluate its influence on operational performance, and propose strategic recommendations to enhance its wider implementation. A quantitative research methodology was employed, collecting data through surveys from 182 pharmaceutical industry professionals, including production managers, quality assurance personnel, and regulatory compliance officers. These professionals were selected based on their direct involvement in PAT implementation. The data were analyzed using statistical tools such as SPSS, Microsoft Excel, and Tableau, which provided insights into the effectiveness of PAT in improving manufacturing outcomes The results revealed that PAT adoption positively impacts product quality, operational efficiency, and regulatory compliance, with many organizations reporting reduced batch failures, improved product consistency, and enhanced real-time monitoring of manufacturing processes. However, the study also identified significant barriers to PAT adoption. High initial investment costs, a shortage of skilled workforce, and complex regulatory requirements were found to hinder widespread implementation. Based on these findings, the study recommends addressing these challenges by providing financial incentives, improving workforce training, and offering regulatory support to facilitate smoother integration of PAT. Furthermore, the research emphasizes the importance of exploring the long-term impact of PAT on manufacturing efficiency and the potential role of external collaborations in overcoming the barriers to adoption. This research provides valuable insights for industry stakeholders and policymakers, highlighting the importance of PAT in optimizing pharmaceutical manufacturing processes in India. It contributes to a better understanding of how PAT can enhance manufacturing viii efficiency while ensuring regulatory compliance, ultimately fostering industry growth and competitiveness in the global pharmaceutical market.
Clear Medication Labels for Better Public Health Outcomes: Tackling Non-Adherence in India
(Innopharma, 2025) Beevi, Beema; Cummins, Alison
In the context of India’s diverse linguistic and educational landscape, medication label clarity plays a critical role in promoting safe and effective medicine use. This study investigates how the clarity of pharmaceutical labelling affects patient adherence, with particular attention to language accessibility and visual design. The primary aim was to examine the impact of label clarity on adherence, while secondary objectives included identifying barriers to comprehension, assessing public health implications, and proposing actionable recommendations. A quantitative survey method was employed, with responses gathered from 142 participants to examine how label design, language accessibility, and digital tools influence patient comprehension and medicationtaking behaviour. The findings revealed that over half of participants reported occasionally or frequently deviating from label instructions. This behaviour was closely linked to factors such as complex terminology, small font size, and the exclusive use of English on labels. In contrast, respondents who encountered clear, visually accessible labels with simplified language and pictograms reported better understanding and adherence. The results further demonstrated a strong public preference for multilingual labelling, colour coding, and the integration of QR codes and digital tools to support comprehension, especially among diverse linguistic groups. An overwhelming majority of 95.8% of respondents considered label standardisation important for patient safety and public health. These insights highlight the urgent need for pharmaceutical labelling reform to ensure inclusivity, reduce preventable medication errors, and improve health outcomes. This dissertation concludes by offering practical and policy-oriented recommendations. These include the adoption of user-friendly design features, incorporation of regional languages, and digital enhancements, with suggested implementation through national regulatory bodies like the Central Drugs Standard Control Organisation (CDSCO). Limktations of the study are acknowledged, particularly the absence of inferential analysis, and future research is recommended to explore causal links between label improvements and long-term adherence behaviour across wider populations.
Evaluating the effectiveness of supplier quality management practices in enhancing supply chain performance within pharmaceutical quality management systems
(Innopharma, 2025) Thula, Anusha; Chiedozie, Chiamaka
This study investigates the implementation and effectiveness of Supplier Quality Management (SQM) practices in organizations, focusing on these practices influence on supply chain reliability, regulatory compliance, cost efficiency and technological integration. The core objective was to identify which factors significantly affect SQM effectiveness and how organizations respond to challenges and opportunities in supplier management. In this research, a positivism philosophy with deductive approach is adopted to examine the impact of SQM on supply chain performance. A quantitative, cross-sectional research methodology was used, with data collected through structured questionnaires and non-probability purposive sampling was applied to target industry professionals. Data analysed by SPSS including descriptive statistics to determine variable relationships and the capabilities of selected variables. In the process all ethical procedures are duly abided and followed. The findings of this study indicated a moderate level of SQM adoption across the sample, with variability in how frequently audits are conducted and how advanced technologies are integrated into quality systems. Notably, a significant positive correlation between SQM practices and regulatory compliance strengthens the industry standards and technology use is positively linked to cost efficiency, indicating the reduction in operational costs. Conversely, a significant negative correlation between the effectiveness of quality agreements and supply chain reliability, suggests a mismatch in expectations or execution. Regression results demonstrated that the model explained approximately 14.9% of the variance in SQM practices indicating a moderate relationship between the predictors and dependent variable. The ANOVA test supported the model’s statistical significance (F = 3.037, p = .009), confirming that the selected independent variables collectively have a meaningful impact on SQM outcomes. In conclusion, SQM practices significantly improves supply chain performance by the use of advanced technologies, enhancing regulatory compliance and operational efficiency but challenges remain in aligning with supplier non-compliance and reliability. Furthermore, future research should consider these insights for continuous improvement, strategic investment in digital tools and stronger supplier collaboration frameworks to support long-term quality objectives.
Assessment of Quality Control Processes in Genetically Engineered Cell Lines in Ireland: An Impact on Biopharmaceutical Product Consistency
(Innopharma, 2025) Sera Johnson, Jeamy; Reagan, Regina; Anaedu, Prosper
Introduction: The growing complexity of biopharmaceutical products derived from genetically engineered cell lines necessitates robust quality control (QC) systems to ensure product consistency, safety, and efficacy. In Ireland, where the biopharmaceutical sector continues to expand, understanding how QC processes are applied and optimized is vital for maintaining regulatory compliance and public trust. This study explores the role of QC in genetically engineered cell line production and its influence on batch consistency, focusing on operational practices, challenges, innovations, and cost-effective strategies. Methods: A qualitative research approach was employed, guided by an interpretivist paradigm to capture the nuanced experiences of industry professionals. Data was collected through semi-structured interviews with seven QC professionals from various Irish biopharmaceutical firms. Purposive sampling ensured participants held relevant expertise. Thematic analysis was conducted following Braun and Clarke’s six-phase method, enabling the identification of patterns and themes that aligned with the study’s five objectives. Results: Six major themes and twenty-three subthemes were identified. Key findings revealed that QC significantly affects product consistency through SOP adherence, potency monitoring, and gene expression validation. Challenges included resource constraints, regulatory fragmentation, and training gaps. Innovative practices such as realtime monitoring, AI integration, and omics-based analysis are emerging as solutions, although barriers like cost and infrastructure remain. Cost-effective strategies such as multi-use systems, shared resources, and outsourcing were highlighted, especially for small-to-medium enterprises. Ethical and societal responsibilities were also seen as integral to modern QC. Conclusions: The study contributes meaningful insights into how QC is practiced in Ireland’s biopharmaceutical sector, confirming that robust, adaptive, and ethically aligned QC systems are essential for consistent and compliant biomanufacturing. It recommends harmonization of standards, investment in training, and broader adoption of innovative and lean QC practices. These findings support policy, operational, and academic improvements in global QC systems.
Enhancing Patient Safety through Error Reduction in Pharmaceutical Dispensing Practices in South Dublin
(Innopharma, 2025) Anupriya; Malone, Joanne
This dissertation investigates how patient safety can be improved by reducing dispensing errors in community pharmacies in South Dublin. Dispensing errors represent a critical risk in the pharmaceutical care process, with the potential to cause anything from minor health issues to lifethreatening consequences. The study is guided by three core research questions focused on identifying the most common types of dispensing errors, understanding their underlying causes, evaluating the effectiveness of existing safety strategies and proposing targeted interventions to improve accuracy and patient safety in pharmacy practice. A qualitative research design, grounded in an interpretivist philosophy, was adopted to explore the perspectives of pharmacy staff regarding dispensing errors and safety practices. Primary data were collected using semi-structured interviews, distributed via Google Forms, allowing participants to respond in a flexible and self-paced manner. Convenience sampling was used to select pharmacists and pharmacy technicians with at least one year of dispensing experience from three community pharmacies in South Dublin. Data were analysed using Braun and Clarke’s six-step thematic analysis framework. Ethical approval was obtained from Griffith College, and ethical standards were upheld through informed consent, anonymity, and secure data handling. The findings revealed that dispensing errors were often linked to human fatigue, workplace distractions, inadequate training, and underuse of available technologies. Although safety measures like Standard Operating Procedures (SOPs), barcode scanning, and double-checking systems were present, inconsistent implementation reduced their effectiveness. The study recommends improving staff training, fostering stronger use of digital tools, and reinforcing procedural compliance to enhance dispensing accuracy. These evidence-based insights can support pharmacy managers, healthcare policymakers, and practitioners in developing safer, more reliable community pharmacy environments
Assessing the Feasibility of Implementing a Pharmacy- Led Medication Take-Back System in Kerala: A Comparative Analysis of France’s Cyclamed Model
(Innopharma, 2025) Pankey Sadanam Omanakuttan, Madhuralekshmi; Byrne, Philip
Improper disposal of unused and expired medicines poses significant risks to public health and the environment, particularly in areas like Kerala, India, where structured disposal systems are lacking. This research investigates the possibility of introducing a pharmacy-led medication takeback initiative in Kerala, inspired by the CYCLAMED program successfully implemented in France. The study utilized a quantitative methodology, collecting data from pharmacists in diverse settings across Kerala to assess existing disposal habits, awareness levels, practical challenges, and readiness for such a program. Additionally, secondary sources were reviewed to examine the operational strengths and outcomes of the CYCLAMED model. Findings show strong support among pharmacists for a take-back initiative, with 73% willing to participate and over 70% believing their pharmacies have the resources to implement the system. Nonetheless, several challenges were identified, including unclear regulatory frameworks, limited public awareness, inadequate infrastructure, and financial constraints. Rural pharmacies, in particular, reported lower preparedness, emphasizing the need for tailored approaches in these regions. A majority of respondents highlighted the importance of government-led education campaigns, clear regulatory framework, and financial assistance as key enablers of success. Overall, the study concludes that a pharmacy-led take-back system is both practical and needed in Kerala, provided that current gaps are addressed through coordinated policy, regulatory reform, and community engagement. Drawing insights from international practices, the research recommends a comprehensive strategy involving collaboration between healthcare stakeholders, government authorities, and the public. Such a system could play a crucial role in improving pharmaceutical waste management, safeguarding public health, and promoting environmental sustainability in the region.
Comparative Analysis of Over The Counter (OTC) Pain Reliever Recalls Due to Quality Issues: A Case Study of Ireland V/S India
(Innopharma, 2025) Manoj, Aleena; Priscilla Ugwu, Ganiru
This study examined the differences in recall practices for over- the counter (OTC) pain relievers in Ireland and India, focusing on quality related issues, regulatory enforcement and recall outcomes. With increasing reliance on OTC medications such as paracetamol and ibuprofen for self-medication, ensuring drug quality and safety is paramount. The study explores the differences between Ireland’s centralised, EU-aligned regulatory model governed by the Health Products Regulatory Authority (HPRA) and India’s decentralised recall system under the Central Drugs Standard Control Organisation (CDSCO). Using a mixed-methods approach, recall data from the past 2 years were analysed alongside expert interviews to categorise recall causes and evaluate the effectiveness of recall systems. It was shown that Ireland’s centralised, Eu aligned recall framework enables quicker and more transparent recall execution compared to India’s decentralised and inconsistently enforced system. Contamination and mislabelling were identified as the leading causes of recalls, with India exhibiting a higher frequency of such events due to weaker post-marketing surveillance and inadequate regulatory infrastructure. The findings revealed significant gaps in recall tracking and consumer notification in India, while Ireland faced challenges related to Eu coordination delays. The analysis highlighted that despite regulatory progress in both countries, key gaps persist in recall traceability, communication and stakeholder compliance. India’s fragmented recall structure hampers timely action while Ireland reliance on EU coordination can create inter-agency delays. The conclusions drawn from these findings suggest that regulatory efficiency, digital traceability and public communication are critical in safeguarding patient safety. This dissertation concludes that effective recall management requires strategic reforms tailored to each country’s regulatory landscape. enforcement consistency and public communication. Strategic recommendations were proposed, including the implementation of centralised recall database in India, adoption of digital traceability systems, greater consumer education efforts and greater alignment with global best practices. These measures are essential for reducing the occurrence and impact of substandard OTC pain relievers and tom restore public trust in pharmaceutical quality control. The study underscores the need for harmonised international best practices to improve drug safety and protect public health.
A study on knowledge, acceptability, barriers and economic considerations of human papillomavirus and its vaccination among unvaccinated Indian adult
(Innopharma, 2025) Puthiya Purayil, Rishab; Vasquez Robinet, Cecilia
This study evaluates the knowledge, acceptability, perceptions of barriers, and cost of HPV infection and vaccination among unvaccinated Indian adults in the context of rising health concerns related to HPV and historically low vaccine uptake. It used a quantitative crosssectional study design, and thirty-three closed-ended questions from a structured online survey were used to collect data. Research participants were recruited between March and early May 2025 from urban, suburban, and rural settings in India and were adults, aged 18 and older. Descriptive statistics and chi-square tests p<0.05 were run on a final sample of 248 eligible responses to examine associations between demographics and knowledge or acceptance levels. Results revealed that 30.65% of participants were aware of how HPV is spread, 73.39% had heard of the HPV vaccine, and 6% were aware of the screening process. About 51.6% of respondents had moderate or low knowledge of prevention, compared to 48.4% who had high knowledge. The research revealed no significant statistical relationships yet female survey participants from cities with higher earnings and better education outcomes tended to know more about these vaccinations. Most common barriers faced by men against vaccination was because they encountered cost, lagging knowledge as well as insufficient healthcare guidance and targeted stigma. In addition, while 83% identified cervical cancer as a public health problem, the nonavalent vaccine generated low willingness to pay as financial limitations were a major barrier. No significant relationship was found between the level of Knowledge and the age, gender or residence of the population according to Chi-Square tests, however relationship was found between age and acceptability levels. The findings confirm that awareness around the risks associated with HPV still leaves a gap in knowledge and presents socio- cultural barriers. High acceptability rates stress the importance of better education together with healthcare provider engagement and government-supported vaccine subsidies to boost vaccination rates. In India the burden of HPV disease can be significantly reduced by incorporation of HPV vaccination into the national immunization program, laying emphasis on gender-neutral vaccination policies, and focusing on removing myths and misconceptions about the vaccine. Overall, this study provides important information to those invested in increasing adult vaccination rates in a public health approach that gives people information, access, and affordability
Blending Nature and Technology: Optimizing Tinosporaside, a Natural Lead, for Advanced COVID-19 Therapy
(Innopharma, 2025) Saji, Christy; Vendrell, Dr. Victor David
This study explored the antiviral potential of Tinosporaside, a natural compound found in Tinospora cordifolia, and its chemically modified versions, to identify a new treatment strategy against COVID-19. The research focused on two important viral enzymes-Mpro and PLpro, that are essential for the virus to replicate and weaken the immune response. This research employed a quantitative, computational methodology rather than a survey-based approach. Techniques such as molecular docking and molecular dynamics simulations were used to design and evaluate 56 Tinosporaside analogs. One particular derivative, T46, stood out for its strong and stable binding to both enzymes. It exhibited better performance than the original compound and possessed favorable druglike properties, including high absorption, low toxicity, and chemical stability. Small structural modifications to the compound, such as the addition of a pyrrole ring, carboxylic acid, and a bromine atom, played a crucial role in enhancing its effectiveness. Further computer simulations confirmed that T46 could interact effectively with both viral targets, potentially disrupting the virus’s ability to function. These findings suggest that T46 has strong potential as a lead compound for future antiviral drug development. While the results are based on computer simulations, they provide a solid starting point for laboratory experiments and, eventually, real-world applications. This work also highlights how natural compounds can be refined and repurposed using modern tools to fight emerging diseases like COVID-19.
Consumer Trust in Ai Chatbots for Otc Medication Advice—A Pilot Study in Ireland and India
(Innopharma, 2025) Jose, Abhirami; Keogan, Justin
Artificial intelligence (AI) chatbots are increasingly used in healthcare, yet questions remain about consumer trust, particularly in providing over-the-counter (OTC) medication advice. This dissertation evaluates consumer trust and satisfaction with AI chatbots and how cultural, regulatory, and experiential factors shape trust. A mixed-methods design grounded in a realist philosophical approach was adopted. The research collected quantitative data through surveys (n=153) and qualitative data via semistructured interviews. Quantitative analysis employed descriptive statistics, t-tests, correlations, and regression modelling, while qualitative data were analysed thematically through the lens of the trust–accuracy paradox and cultural frameworks. Findings show that trust in chatbots is conditional and there are significant differences between the two countries. Indian consumers reported higher acceptance of chatbots by using chatbots often for minor ailments such as coughs or fever linked to limited healthcare access. However, advice was usually cross-checked with family or doctors showing conditional trust. Irish consumers relied more on pharmacists due to easier access to professional care. Survey data showed moderate trust in chatbot accuracy (22% scored 3/5) but stronger trust in pharmacists (38% scored 5/5). Pharmacists were aware of chatbot use, yet many expressed concerns about misleading or incomplete advice. Across both countries, pharmacists remained the benchmark of credibility. The study contributes to understanding how trust in AI healthcare tools differs across different cultural and regulatory settings for example, Indian participants demonstrated necessity-driven trust valuing accessibility and speed while Irish participants exhibited regulation-driven caution emphasising privacy and accountability. Gender differences were also observed, with men showing greater trust than women. The study contributes to theory by extending models of trust in automation demonstrating that satisfaction and reassurance often outweigh accuracy in driving adoption Overall, the research highlights that trust in healthcare AI is shaped not solely by technical accuracy but by user experience, cultural context, and systemic healthcare realities, underscoring the importance of responsible and contextualised deployment.
Perceptions of Digital Health Information Sources and their Influence on Vaccine Confidence Among Parents of Infants in Ireland
(Innopharma, 2025) Baby Abraham, Sherin; McHugh, Catherine
Introduction: Parents are increasingly turning to digital media for vaccine information, but platforms vary in credibility and emotional tone. This study aimed to evaluate how digital media influences vaccine confidence in Ireland. The study objectives were to: (1) assess parental perceptions of digital health information sources and their impact on vaccine confidence using a Likert-scale questionnaire; (2) identify commonly used digital platforms and evaluate their perceived trustworthiness and influence; (3) explore perceived risks and concerns related to online vaccine information; and (4) determine how these findings can inform pharmaceutical companies' digital communication strategies Methods: This study involved a cross-sectional online survey of parents or caregivers of children aged 0–5 years in Ireland (N = 104). Items were rated on a 3-point Likert scale (Agree = 1, Neutral = 2, Disagree = 3). Analysis included: descriptive statistics; Spearman's rank correlations for ordinal data; χ²/fisher’s exact tests for associations; McNemar’s tests to compare platform use and trust levels; Kruskal– Wallis tests for education versus digital literacy. Significance level set at α = 0.05 Results: The analysis showed that official health websites (HSE/NHS) were the most used (92/102, 90.2%) and the most trusted (88/105, 83.8%). Google Search was widely used (50/102, 49%) but infrequently trusted (7/105, 66.9%); McNemar's test confirmed a significant gap between usage and trust (p < 0.001). Notable correlations included: use of official digital sources with reading vaccine stories (ρ = 0.273, p = 0.005) and perceiving that some online content benefits pharmaceutical companies (ρ = 0.222, p = 0.024); use of unofficial digital sources with reporting a decision not to vaccinate (ρ = -0.197, p = 0.045); exposure to opposing views with reporting that online information influenced vaccination decisions (ρ = 0.259, p = 0.009); perceptions that stories impact confidence with online information shaping decisions (ρ = 0.258, p = 0.009). Trust in official sites was linked to fewer reports of opting out of vaccination (χ²(1) = 15.75, p = 0.002), while trust in social media was associated with more refusals (Fisher p = 0.005). Education level was not significantly associated with digital literacy (H(3) = 6.85, p = 0.077). Conclusions & Recommendations: Irish parents distinguish clearly between digital sources, favoring official platforms and distrusting unofficial ones. Narrative content (opposing views and emotive stories) correlates with lower vaccine confidence, whereas trust in official sites aligns with higher confidence. The findings suggest that pairing credible information with emotionally engaging narratives and improving the visibility of official content online could enhance vaccination confidence, ultimately increasing vaccine uptake. It is recommended that pharmaceutical companies act as key communicators, supported by healthcare providers as the primary source of vaccine information.
Integrating Artificial Intelligence into Root Cause Analysis for CAPA systems: A Survey Based Study on Perception, Readiness and Implementation Challenges in the Indian Pharmaceutical Industry
(Innopharma, 2025) Vinod, Paul; Kelly, Megan
This study investigated the perception, organizational readiness and implementation challenges of integrating Artificial Intelligence (AI) in to Root Cause Analysis (RCA) within Corrective and Preventive Action (CAPA) systems in the Indian pharmaceutical industry. A quantitative survey was conducted among 101 professionals working in quality assurance, quality control, manufacturing and regulatory roles. Collected Data were analyzed using descriptive statistics, frequency distributions and measures of central tendency to identify existing attitudes, readiness levels and perceived barriers. The results showed that the majority of respondents recognized AI’s potential to enhance the RCA accuracy, reduce human errors and improve compliance with Good Manufacturing Practices (GMP) standards, with two-third of total sample size agreeing on its benefits for efficiency and decision making. However, readiness levels were not found to be same, with approximately 60% reported having some relevant technical infrastructure and other 40% believed their organizations had both the technology and skilled personnel required for effective implementation. Key barriers included high implementation costs, limited AI expertise, resistance to change and uncertainty about regulatory acceptance. Participants have identified a strong need for clearer regulatory guidelines, targeted training programs, pilot implementation projects and improved data quality and security to support AI adoption. The findings indicate that although optimistic belief towards AI adoption in CAPA systems is strong, there are some practical limitations which constrain the current progress. This study concludes that successful integration will require coordinated efforts between industry stakeholders and regulators, strategic investments in infrastructure and training, and structured change management initiatives. This research contributes real world data on an underexplored geographical context, giving a combined view of perceptions, readiness and challenges to help shaping the policies and organizational strategies which promote AI adoption. Recommendations includes initiatives for small scale pilot programmes, promoting industry-regulator collaborations and developing more regulatory guidelines for AI- validation. In future, more investigations has to be done in relation to changes in AI-adoption over time, assessment of cost-effectiveness and comparisons with other regulated industries.
Regulatory Frameworks for Obtaining and Renewing Marketing Authorisations of Generic Paracetamol 500 mg Tablets Imported from the United States: A Comparative Analysis of HPRA (Ireland) and AGEMED (Bolivia) in 2024, Using Paracetamol as an Illustrative Example.
(Innopharma, 2025) Lucia Fernandez Rodriguez, Patricia; Finn, Deirdre
This study compared how two national agencies, HPRA in Ireland and AGEMED in Bolivia, approve and renew the marketing authorisations of generic paracetamol 500 mg tablets imported from the United States. The research aimed to identify the main differences in legal requirements, timelines, safety measures, and documentation, in order to recommend ways to improve regulatory efficiency and public access to quality medicines in Bolivia. A mixed-methods approach was used. First, legal and regulatory documents were reviewed. Then, an online survey was conducted with pharmaceutical professionals in Bolivia to collect both quantitative data (such as timelines) and qualitative insights (such as personal experiences and challenges). The focus was on real-life practices, especially for the approval and renewal processes. The results showed that Ireland’s regulatory process is more structured, digital, and aligned with international standards. HPRA requires bioequivalence studies, digital submissions, and ongoing safety monitoring. In contrast, AGEMED in Bolivia uses paper-based systems, does not require bioequivalence for generics, and often has slower timelines due to manual procedures. Survey participants highlighted delays, lack of clarity, and the need for system updates. In conclusion, the study found that Bolivia could improve its regulatory framework by adopting digital tools, requiring bioequivalence studies for generic medicines, and updating outdated legal guidelines. These changes could help make the approval process faster, safer, and more transparent. By learning from Ireland’s experience, Bolivia has the opportunity to modernise its system and improve public health outcomes.
Doctors' Perspectives On The Effectiveness Of Telemedicine Consultations In Managing Patients With Chronic Conditions In Kerala
(Innopharma, 2025) Nath, Gopika; Vasquez, Cecilia
This dissertation investigates Kerala physicians' opinions regarding the use of telemedicine in the treatment of chronic illnesses. The growing significance of digital healthcare delivery, especially in situations where continuity of care and accessibility are critical, served as the impetus for the study. Introduction: The research background, justification, goals, and questions were presented, establishing telemedicine as a game-changing instrument in India's healthcare system. The study was framed using the Technology Acceptance Model, which emphasises perceived utility and ease of use in driving adoption, and it described the issue of limited access to consistent chronic disease care. Literature Review: A review of the literature based on both domestic and international data was provided in the study. It looked at patient outcomes, adoption barriers, the efficacy of telemedicine in chronic care, and pertinent theoretical frameworks. The study was justified by identifying gaps, especially the need for context-specific evidence on doctors' perspectives in India. Methodology: This chapter described philosophy, design, data collection and analysis in detail. Senior specialists in Kerala participated in qualitative interviews and quantitative survey data as part of a mixed-methods approach. In order to ensure rigour, reliability, and ethical compliance, sampling, data collection methods, and analytical techniques, such as thematic analysis and statistics analysis using graphics like pie charts, were described. Results and discussion: Physicians believed that telemedicine was useful for facilitating ongoing monitoring, decreasing hospital stays, and increasing treatment adherence. However, its potential was constrained by issues like inadequate internet connectivity, a lack of integrated diagnostic support, and digital illiteracy. These findings were discussed in light of previous research and theoretical understandings, reaffirming the significance of perceived utility, usability, and supportive infrastructure in the adoption of telemedicine. Conclusion: This chapter concluded the study, summarising findings, acknowledging limitations, and offering practical and academic recommendations. It suggested strategies including structured training, digital literacy initiatives, infrastructural integration, and theory-based future research. The reflection underscored the importance of evidencebased approaches in guiding telemedicine practices and policy.
Adoption and Manufacturing of Biosimilars for Autoimmune Diseases in Jordan and the Middle East: Key Barriers, Opportunities, and Global Collaboration Models
(Innopharma, 2025) Abu Sadaa, Mohammad; 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.
Bridging the Gap: How Digital Twins Can Address Clinical Trial Delays in India
(Innopharma, 2025) Sreedhar Vysiapat, Abna; Rizzarello, Francesca
Clinical trials in India are often delayed due to regulatory bottlenecks, site-level inefficiencies, and patient recruitment challenges. Digital twin technology—virtual replicas of real-world processes—offers potential to streamline trials through simulation, optimisation, and predictive modelling. However, research on its application in India remains scarce. This study aimed to explore whether digital twins could help reduce trial delays and to assess the perceptions and readiness of clinical research professionals in India. Methods A mixed methods strategy was adopted, combining primary and secondary research. Surveys were conducted with 149 clinical research professionals to gather quantitative insights, while in-depth interviews with 8 experts provided qualitative perspectives. Quantitative data were analysed using descriptive statistics, and qualitative data were examined through thematic analysis to identify themes and sub-themes aligned with the research objectives. Results Findings showed that delays were primarily driven by slow regulatory approvals, ethics committee backlogs, site-level inefficiencies, and recruitment difficulties. Awareness of digital twins was limited, but professionals recognised their potential to improve protocol design, patient recruitment, and trial predictability. Key barriers included high costs, infrastructure limitations, regulatory uncertainty, and lack of expertise. Despite these obstacles, respondents expressed cautious optimism about adoption, citing ongoing digitalisation trends, workforce training, and evolving regulatory frameworks as enablers. Conclusion The study concludes that while India’s clinical trials continue to face systemic delays, digital twin technology represents a promising avenue for improvement. The research fills a regional gap in the literature, offering both conceptual insights and practical recommendations for future adoption. Broader stakeholder engagement and pilot projects will be crucial to validate its effectiveness in real-world settings
Biosimilars of Adalimumab In Eu: Addressing Regulatory Barriers and Market Dynamics to Enhance Accessibility and Affordability
(Innopharma, 2025) Shajimon, Manjusha; Vecchi, Alessandra
The research examined regulatory obstacles together with market dynamics which affect EU adalimumab biosimilars adoption to enhance their market availability and economic value. The research examined regulatory variations together with market elements and pricing systems and stakeholder perspectives to create evidence-based solutions. A quantitative survey method served as the research methodology to gather data from healthcare professionals and policymakers and patient representatives across multiple EU member states. SPSS analysis of data included descriptive statistics as well as correlation and regression techniques. The European Medicines Agency (EMA) centralised approval did not eliminate significant regulatory fragmentation. National policies regarding substitution practices together with reimbursement systems and procurement procedures determine how much biosimilar market adoption will take place. Germany and France showed high biosimilar adoption because their substitution and reimbursement policies were supportive yet Italy and Spain and Bulgaria showed slow adoption because their policies were restrictive and procurement systems were limited. The market dynamics played a significant role in biosimilar adoption because both transparent competitive tendering and originator companies' aggressive discounting and single-supplier contracts affected market competition. Stakeholder opinions regarding biosimilars were influenced by knowledge deficits alongside safety concerns and patient unwillingness to transition from original products. The substitution policy and sustainable pricing strategies emerged as the leading determinants of EU policy harmonisation support according to the correlation analysis. The regression analysis showed that regulatory and market and stakeholder-related factors explain 28.1% of the variance in support for harmonisation indicating multiple barriers to adoption exist. The study demonstrates that EU-wide standardised substitution and reimbursement systems combined with clear procurement methods and targeted educational initiatives for stakeholders will drive biosimilar acceptance by promoting trust and comprehension. The study advises that policy alignment should be supported while long-term multisupplier contracts should be established and savings from cost reduction should fund patient care and structured switching protocols with effective communication should be created. The economic and accessibility benefits of EU adalimumab biosimilars depend on solving fragmented regulations and market inefficiencies. The EU will create a sustainable biosimilar market with universal access through unified policy reforms combined with stakeholder education and member state cooperation. The proposed method would reduce healthcare costs while extending access to treatment for patients suffering from chronic inflammatory conditions
A Study of The Key Challenges in the Nigerian Pharmaceutical Industry, With Emphasis on the Regulation and Quality of Medical Devices
(Innopharma, 2023) Osidele, Mosopefoluwa; Vasquez-Robinet, Cecilia
The Nigerian pharmaceutical manufacturing sector holds significant importance for Nigeria's economy, particularly in relation to medical devices. Extensive research conducted on the Nigerian medical device industry has highlighted numerous challenges that hinder the sector's development. This study aims to investigate the challenges faced by the Nigerian pharmaceutical industry, with emphasis on the regulation and quality aspects of medical devices. Usar et al. (2017, p. 86-91). emphasize the weak state of pharmaceutical regulation in Nigeria, characterized by irregular inspections, inadequate enforcement, widespread violations, and resultant negative health outcomes. To structure the research process, the study adopts the Research Onion framework proposed by Saunders, Lewis, and Thornhill in 2009. The interpretivist research philosophy plays a central role in this dissertation's context. Employing a deductive research approach, the study aims to collect data and formulate a theory based on the obtained results Saunders et al. (2019, p. 207). A case study strategy is employed to gain in-depth understanding of the challenges, particularly in the regulatory and quality aspects, faced by the two selected medical device manufacturing firms and the regulatory authorities that restrict their performance. The research design involves a mono-method approach for data collection. The gathered data is then analyzed thematically, contributing to the overall research findings. The study reveals significant weaknesses in the current regulatory framework for medical devices, including poor implementation of guidelines, lengthy processing times, and inadequate post-marketing surveillance. Regarding challenges related to the manufacturing of high-quality medical devices, the study identifies the lack of raw materials and the unavailability of custom-made machine parts as key factors affecting the production capabilities of medical device manufacturing firms in Nigeria. Insufficient funding, policy inconsistencies, regulatory duplication, and high inspection costs are identified as factors contributing to the ineffectiveness of medical device regulation and registration. Finally, in terms of the efficacy of quality and safety management practices, the study concludes that the existing practices are inadequate in ensuring the utmost safety of the public.ts.

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