International Journal of Science and Research (IJSR)

International Journal of Science and Research (IJSR)
Call for Papers | Fully Refereed | Open Access | Double Blind Peer Reviewed

ISSN: 2319-7064


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Short Communication | Pharmaceutical Science | India | Volume 12 Issue 11, November 2023


Embracing Generative AI in Pharma Regulatory Affairs - An Industry Perspective

Dr. Rita Shah


Abstract: Generative AI has become a ubiquitous term across industries, and the pharmaceutical sector is no exception. This article delves into the burgeoning field of generative AI in the pharmaceutical industry, which is poised to reach a market size of USD 2258.1 Mn by 2032, according to industry analysts (1). With the pharmaceutical industry approaching a 2 trillion valuation, the urgency to harness the power of AI and Generative AI to expedite research and development processes is evident. This article explores the current state of generative AI in the pharmaceutical industry, showcasing real - world applications like ChatGPT and OrcaGPT in regulatory processes that are reported to have significantly reduced submission times. Additionally, it discusses the wide - ranging capabilities of generative AI in the regulatory context, from content generation to knowledge reuse, and highlights key considerations such as accuracy, data privacy, and ethical obligations. The industry's readiness for embracing generative AI is examined, emphasizing the need for transformational thinking, trust - building, and ROI assessment to fully realize the potential of Gen AI in Regulatory Affairs.


Keywords: Generative AI, Pharmaceutical Industry, Regulatory Affairs, AI Applications, Data Privacy, Data Integrity


Edition: Volume 12 Issue 11, November 2023,


Pages: 1051 - 1052


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