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Session 5B: Tools and Technology Track - Structured Content Management
Session Chair(s)
Sarah Powell, RAC
President
Powell Regulatory Services, United States
This session will have presentations on: A Custom Database to Manage Key Regulatory Aspects of Investigator Initiated INDs/IDEs in an Academic Research Center, Deriving Business Value from Rules-driven Automated Assembly of Narratives: A Structured Content Management Success Story, and Comparison of CRT data in legacy vs. SDTM formats.
Speaker(s)
Presenter
Shankar Srinivasan, PhD, MBA
Mayo Clinic, United States
Senior Regulatory Specialist; Office of Research Regulartory Support
Presenter
Christina Sacro
Sanofi, United States
Transparency Manager
Presenter
Shifu Zhao, PhD
FDA, United States
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