This repository is a collection of research and scholarly output from Innopharma.
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Item Assessing public preferences and willingness to use telepharmacy services in south India(2024)Telepharmacy is an innovative healthcare delivery method that leverages digital technology to provide remote pharmaceutical services. This study explores the adoption and acceptance of telepharmacy in South India, focusing on public preferences, barriers to adoption, and the influence of socioeconomic factors. Key findings suggest that accessibility to traditional pharmacy services, socioeconomic status, and public awareness significantly impact the acceptance of telepharmacy. The study also identifies operational challenges, privacy concerns, and reluctance to use technology as barriers. By analyzing these factors, the research provides valuable insights into the current state of telepharmacy in South India and offers recommendations for overcoming obstacles to its broader adoption, aiming to enhance healthcare delivery and patient outcomes in the region. Methodologically the study adopts a positivist philosophy, utilizing a deductive approach to test existing theories in a new context. The research strategy involves quantitative data collection through structured online surveys, targeting a diverse population sample using stratified random sampling. Data analysis relies on descriptive statistics to summarize demographic characteristics, awareness levels, and public preferences. Ethical considerations, including informed consent, privacy, confidentiality, and minimizing bias, are carefully addressed to ensure the validity and integrity of the research. The conceptual framework integrates key factors influencing telepharmacy adoption, such as sociodemographic factors, accessibility, technological infrastructure, and privacy concerns. This methodology provides a robust and systematic approach to understanding the determinants of telepharmacy acceptance in South India, offering valuable insights for enhancing digital healthcare services in the region. The analysis reveals a strong awareness and positive attitude toward telepharmacy services among the South Indian population. Key benefits include convenience, reduced travel time, and access to expert pharmacists. However, barriers such as privacy concerns, preference for face-to-face interaction, and lack of trust hinder widespread adoption. The study also highlights the significant influence of education level on telepharmacy usage. While there is a high interest in learning more about telepharmacy, addressing these barriers and enhancing awareness will be crucial for broader acceptance and integration of telepharmacy in healthcare. The study highlights that South Indians value telepharmacy for its accessibility, convenience, and cost-effectiveness, with younger individuals showing a greater willingness to use it. Major barriers include poor internet connectivity, lack of awareness, and trust issues. Future research should focus on larger, more diverse samples and address socioeconomic and technological factors.Item Public awareness and utilization of the adverse drug reaction reporting system among residents of Dublin: a study of knowledge, barriers, and facilitators(2024)Adverse Drug Reactions (ADRs) pose significant challenges to public health, necessitating robust pharmacovigilance systems to monitor and mitigate these risks. This study assesses public awareness and utilization of the Adverse Drug Reaction (ADR) Reporting System in Dublin, focusing on identifying barriers to reporting and evaluating the effectiveness of current educational campaigns. A mono quantitative approach, involving a structured online survey, was employed to gather data from 131 residents in Dublin. The findings reveal that 89% of respondents are aware of ADRs, but only 67% are familiar with adverse event reporting forms. Furthermore, demographic factors such as education level (71% of respondents had a master's degree or higher) and occupation (39% of participants were healthcare professionals) significantly influence knowledge and participation in ADR reporting. Despite the high level of general awareness, 33% of participants had never seen an ADR reporting form, highlighting a gap in effective public engagement. Substantial barriers to reporting include the perceived complexity of the process and limited awareness of where and how to report. Additionally, 78% of respondents are familiar with the term 'pharmacovigilance,' but only 56% have reviewed related regulatory documents. The study also found that existing educational campaigns are insufficient in significantly enhancing public engagement with the ADR reporting system. Recommendations include simplifying the reporting process, enhancing public education efforts, and increasing the visibility of ADR reporting channels. These improvements are critical for strengthening pharmacovigilance practices, ensuring better drug safety, and ultimately improving public health outcomes in Dublin.Item How Can Quality by Design Enhance Biopharmaceutical Manufacturing in India? Exploring Strategies and Outcomes(2024)This study investigates the integration and impact of Quality by Design (QbD) principles within the Indian biopharmaceutical manufacturing sector. As the industry expands, driven by the demand for affordable biologics and the necessity to meet stringent international quality standards, QbD emerges as a pivotal approach. This research evaluates the current level of QbD integration, explores specific strategies employed by manufacturers, and analyses the outcomes on product quality, regulatory compliance, and operational efficiency. It also identifies significant barriers to QbD implementation, including technical expertise gaps, high upfront investment costs, and regulatory challenges. The study is based on a comprehensive survey conducted among industry professionals. The survey employed structured questionnaires designed to collect quantitative data on the perceptions, experiences, and practices related to QbD implementation within the sector. Data analysis was performed using statistical methods, including descriptive statistics to summarize the data and inferential statistics to explore relationships between variables, assess the impact of QbD practices, and identify significant trends within the industry. The findings reveal that while QbD is widely recognized for its potential, its implementation remains in the early stages across much of the industry. The results highlight the need for enhanced training, investment in advanced technologies, and stronger regulatory alignment to facilitate broader and more effective QbD adoption. These insights are intended to guide policymakers, industry leaders, and regulatory bodies in strengthening the Indian biopharmaceutical sector through the effective application of QbD principles.Item Evaluating the effectiveness of automated MedDRA coding systems in enhancing pharmacovigilance case processor efficiency and accuracy in India(2024)This dissertation explores the effectiveness of automated Medical Dictionary for Regulatory Activities (MedDRA) coding systems in enhancing the efficiency and accuracy of pharmacovigilance case processing in India. Employing a quantitative approach, the study collected responses from 95 pharmacovigilance professionals across various pharmaceutical organizations in India through a structured survey. The primary focus was on comparing the accuracy of automated versus manual MedDRA coding processes, evaluating the time efficiency of automated systems, and assessing user satisfaction. The results demonstrated that automated systems significantly improved the speed of coding adverse events. Professionals reported a noticeable reduction in the time required to process cases with automated systems compared to manual methods. Similarly, there was a marked improvement in the accuracy of coding with fewer errors and discrepancies noted in automated coding versus manual processes. User satisfaction with automated systems was also high, with participants appreciating the ease of use and the consistent results provided by these systems. The study concludes that integrating automated MedDRA coding systems could enhance pharmacovigilance practices in India by streamlining operations, reducing the likelihood of errors, and improving the overall quality of data. These improvements suggest that automated systems are beneficial for pharmacovigilance activities, supporting their wider adoption within the industry to bolster drug safety monitoring and regulatory compliance.Item The use of Artificial Intelligence in Regulatory Affairs across Europe: Assessing Current Impact and Future Advancements for the Pharmaceutical Industry(2024)In a digital era, scientific and technological advancements undeniably transform and shape diverse sectors, including the pharmaceutical industry. These technologies have profoundly impacted this field, especially using Artificial Intelligence (AI). This current study aimed to identify AI's impact on pharmaceutical regulatory affairs. The objective was to investigate how AI technologies are currently being used and identify future advancements of AI in Regulatory Affairs and the benefits and challenges they provide through the perspective of specialists in the regulatory field in Europe. The study used a quantitative approach through an online survey of eligible regulatory affairs professionals through a cross-sectional design. All data collected and stored by Google Forms was submitted for analysis with the support of Jamovi, a program to help with the study’s analysis. The study comprised 49 validated participants; 45% work as Regulatory Specialists, and most are based in Ireland. Approximately 61% of the respondents have already applied AI systems in their regulatory tasks. This study suggested a correlation among participants who tended to use more AI tools in their daily work routine when they were more satisfied with their training in AI tools and felt more confident in operating these tools. The most common type of AI-driven solutions are NLP tools. The primary purposes of use are administrative tasks (24.72%), data analysis (15.73%), document management (14.61%), and compliance checking (13.48%). The main benefits of AI in the regulatory field are improved efficiency and increased speed; on the other hand, the main challenges to operating these systems are inaccurate results and the fear of receiving unreliable data. Regarding the main obstacles to implementing these AI tools in this sector, lack of expertise and high costs are highlighted. Primordial areas for leveraging AI technologies in the regulatory field are Regulatory Submission Processes (30,93%) and Compliance Monitoring (31,96%). Most respondents expect significant advancements in this topic within 3 to 5 years. According to the study analysis and what is compiled from the most recent literature, there is current progress that could not be considered linear and rapid, especially when involving regulatory requirements that must be addressed. However, it is still very promising, and it will considerably reshape the field in the coming years.
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