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Session 5, Track 4: The Future of Regulatory: Reimagining Operating Models for the Digital and AI Revolution
Session Chair(s)
Cindy Chiu
Senior Director, Regulatory Affairs Operations, Merck & Co., Inc., United States
With a focus on real-world experience and multi-company perspectives, the discussion will delve into how organizations are adapting their operating models and capabilities to a digital future with transformed submissions. Panelists will share practical strategies for aligning global operations, overcoming challenges of fragmented data ownership, and the importance of cross-functional collaboration to reduce cycle times and improve submission quality—all while integrating new digital tools and AI capabilities. By blending insights on operating model redesign with the realities of technology adoption, the session will highlight:
Learning Objective : - Gain actionable strategies for leading technology-driven transformation in regulatory affairs
- Learn practical approaches to optimizing regulatory operating models in the digital era
- Employ guidance on integrating AI and automation while maintaining compliance and business continuity
- Use insights from industry leaders on overcoming common challenges and driving sustainable change
Speaker(s)
Speaker
Helena Corte-Real Correia, PhD
VP, Regulatory Data and Content Lead, F. Hoffmann-La Roche Ltd., Switzerland
Speaker
Tim Twells
VP of Regulatory Affairs, Enabling Functions, Novartis, United Kingdom
Speaker
Mukesh Singhal, MBA
Partner, Deloitte, United States
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