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Session 6, Track 1: Shaping the Future of Regulatory: Trends, AI, and Practical Success
Session Chair(s)
Nimesh Patel
Senior Director of Global Regulatory Systems , Eisai Co., Ltd., United States
This session highlights how regulatory functions are evolving through global technology trends, artificial intelligence, and smarter data strategies. We’ll explore regulatory tech expectations in clinical research, focusing on intelligence and practical implementation. Key insights will cover AI adoption in regulatory, including considerations for success, and the strategic management of regulatory data to enable structured submissions, governance, and analytics. Together, these perspectives provide a clear roadmap for modernizing regulatory operations and achieving practical success.
Learning Objective : - Spot emerging global regulatory trends and understand how they’re reshaping the future of clinical research
- Gain practical insights into AI adoption in regulatory work, with clear considerations for driving success in their own organizations
- Leverage smarter strategies for managing regulatory data to streamline submissions, strengthen governance, and unlock the power of analytics
Speaker(s)
Global Regulatory Tech Expectations: Trends, Intelligence, and Practical Implementation
Kim Gallop
Global Regulatory Specialist, Florence Healthcare, United States
Implementing AI in Regulatory: Key Considerations for Success
Sean Carpenter
Director of Product, Ennov, United States
USE CASE: Strategic Management of Regulatory Data: Enabling Structured Submissions, Governance, and Analytics
Donna Yosua
Director, Global Regulatory Data Management , Merck & Co., Inc., United States
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