Abstract

ARTIFICIAL INTELLIGENCE IN REGULATORY AFFAIRS: GETTING READY FOR THE FUTURE

Ashwini Hanmant Sagar*, Amol Datta Wawdhane, Dr. Vanita Baburao Wadewale and Kapse V. N.

ABSTRACT

The ability of a computer to do tasks associated with human intellect, such as thinking, discovering, and learning from past experience, is known as artificial intelligence (AI). AI can be used to streamline the intricate regulatory affairs for pharmaceuticals. Artificial intelligence (AI) systems can be used to automate regulatory tasks like administrative labor, filling up dossiers, extracting data, auditing, enforcing regulations, and quality control. AI makes connections between processes and streamlines complexity, making management systems more effective. Interaction between humans and AI creates new possibilities in regulatory concerns. Pharmaceutical regulatory affairs (RA) is one of the activities that can profit from the use of artificial intelligence (AI). The application of AI in the pharmaceutical business has a very wide scope and prospects. Artificial intelligence (AI) in the RA has the potential to increase productivity, enhance decision-making, and expedite procedures. This would shorten the time it takes to submit and approve marketing authorization applications and get them to market, giving patients who need them access to therapies more quickly. The possible application of AI to pharmaceutical regulatory concerns is examined in this article.

Keywords: AI, artificial intelligence, regulatory affairs, Robotic process automation (RPA), machine learning, Natural language processing.