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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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 11 Track 1: Improving Regulatory Processes Through Data-Driven Metrics, Generative AI, and Effective Change Management

Session Chair(s)

Katherine  Novak, MS

Katherine Novak, MS

Principal Product Manager

Accumulus Synergy, United States

This is an introductory session focused on how data-driven processes and generative AI can be implemented to improve efficiency in regulatory operations. The session will also highlight the importance of change management and effective change management strategies. The topics include a case study for improving data quality to enhance regulatory metrics, use cases for generative AI to improve accuracy and efficiency in regulatory operations, and how change management is essential for implementing these changes in an organization.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss how to collaboratively define a metrics roadmap focused on a regulatory organization
  • Understand how generative AI can improve efficiency by automating manual and repetitive tasks
  • Gain insight into the benefits of using generative AI in regulatory operations
  • Develop effective change management strategies and communication


Noelia  Plaza

Our Journey to Improve Data Reliability and Establish Regulatory Metrics

Noelia Plaza

Daiichi Sankyo, United States

Director of Process Excellence & Analytics

Leslie  Kitchen, BSN, RN

Generative AI Across Regulatory Operations

Leslie Kitchen, BSN, RN

Merck & Co., United States, United States

Senior Director Regulatory Innovation and Information Management

Kevin M. Costello

Criticality of Change Management during a global RIM implementation

Kevin M. Costello

Astrix Inc., United States

Senior Consultant, Clinical and Regulatory Consulting

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