Masterarbeit

Artificial Intelligence in Regulatory Affairs CMC - Chances and Challenges ***

Marina Semakov (2024)

Summary
Language: English
This thesis examines the transformative potential of Artificial Intelligence (AI) within the Chemistry, Manufacturing, and Controls (CMC) sector of Regulatory Affairs in the pharmaceutical industry. A key challenge in the sector is the manual, time-consuming nature of data handling for regulatory dossier compilation, which is prone to errors and inefficiencies. Through extensive research, practical experience, and feedback from industry experts, regulators, and IT specialists, this study explores the potential of AI to improve these processes.
The research identifies several use cases where AI can significantly improve the efficiency of Common Technical Document (CTD) generation, annual report management, and change and variation management. The thesis also considers the wider implications of AI adoption, including the potential to accelerate the overall regulatory approval process ultimately accelerating patient access to medicines.
Despite the promising capabilities of AI, the thesis identifies significant challenges, such as ensuring data quality, ethical considerations, bridging skills gaps, and developing AI-specific regulatory frameworks. Furthermore, there is a common understanding that while AI significantly aids in decision-making and the performance of routine tasks, it cannot fully replace human oversight and expertise.
Overall, the thesis advocates a responsible, collaborative approach between regulators, industry stakeholders and academia to achieve the full potential of AI in Regulatory Affairs CMC and the pharmaceutical industry in general.
Pages: 84
Annexes: 0