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Bethesda North Marriott Hotel and Conference Center

Feb 02, 2026 10:00 AM - Feb 04, 2026 12:45 PM

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 6, Track 1: Shaping the Future of Regulatory: Trends, AI, and Practical Success

Session Chair(s)

Nimesh  Patel

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)

Kim  Gallop

Global Regulatory Tech Expectations: Trends, Intelligence, and Practical Implementation

Kim Gallop

Global Regulatory Specialist, Florence Healthcare, United States

Sean  Carpenter

Implementing AI in Regulatory: Key Considerations for Success

Sean Carpenter

Director of Product, Ennov, United States

Donna  Yosua

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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