Regulatory AI in Action: Enhancing Product Change Control
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Regulatory AI in Action: Enhancing Product Change Control
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In this episode of the Life Sciences Gen I Exchange podcast, host Agnes Cwienczek from ArisGlobal discusses the impact of AI on regulatory affairs with Preeya Beczek, a regulatory affairs and compliance expert. They explore the use of AI in regulatory impact assessments, emphasizing the importance of speeding up the process, ensuring compliance, and managing complex data flows. The conversation covers the need for governance, accurate data, and prioritizing use cases to derive maximum value. They also highlight the importance of starting small, involving human elements, and the need for the industry to embrace AI technology actively.
00:00 Introduction to Regulatory AI
00:20 Meet the Experts: Agnes and Priya
01:49 The Growing Importance of AI in Regulatory Affairs
04:23 Challenges in Regulatory Impact Assessment
07:27 AI Solutions for Regulatory Challenges
11:07 End-to-End Regulatory Processes
19:22 The Future of AI in Regulatory Affairs
25:44 Final Thoughts and Advice
28:32 Closing Remarks and Next Steps