The use of Artificial Intelligence in Regulatory Affairs across Europe: Assessing Current Impact and Future Advancements for the Pharmaceutical Industry
| dc.contributor.author | Pedro, Brunna Aruajo | |
| dc.date.accessioned | 2024-10-17T09:53:02Z | |
| dc.date.available | 2024-10-17T09:53:02Z | |
| dc.date.issued | 2024 | |
| dc.description.abstract | 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. | |
| dc.identifier.uri | https://hdl.handle.net/20.500.14136/186 | |
| dc.title | The use of Artificial Intelligence in Regulatory Affairs across Europe: Assessing Current Impact and Future Advancements for the Pharmaceutical Industry | |
| dc.type | Thesis |