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Navigating the Rules of Innovation: Regulatory Expectations for Generative AI Use Cases
Session Chair(s)
Oliver Fink, MS
Head Learning, Processes and Digitalization
Boehringer Ingelheim, Germany
This session explores AI's role in pharma, offers regulators' insights and Q&A, introduces a Gen AI validation framework, and showcases use cases in audit report authoring and process/knowledge management chatbot, highlighting ethical, time/cost efficient, and compliant AI adoption.
Learning Objective : Identify regulatory expectations for implementing Generative AI in the pharmaceutical industry, focusing on practical applications such as structured authoring of audit reports, Generative AI validation frameworks, and AI-powered chatbots for knowledge management; Discuss the challenges, user experiences, cost efficiency, and compliance considerations involved in integrating AI into regulated environments.
Speaker(s)
Regulators expecatations and insights into Gen AI
Karen Bleich
FDA, United States
Lead Physician, OMP, CDER
Gen AI-powered structured authoring for audit reports
Srilatha Endabetla, MS
Bristol Myers Squibb, United States
Senior Director, Business Intelligence - Global Quality
Framework for computer system validation of Gen AI
Haleh Valian, PHD
Biogen, United States
Head of Decision Quality Analytics and Innovation
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