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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 8 Track 2: The Value of Reference Models and Data Governance for RIM

Session Chair(s)

Jamie  O'Keefe

Jamie O'Keefe

Head, Clinical & Regulatory Consulting

Astrix, United States

As Regulatory Information Management (RIM) evolves and matures, the value of standardization and data governance shifts from desirable to critical to the success of the program. In this session we will review the progress of the RIM Reference Model team, presenting results of initial test drives of the model, plus updates that have been incorporated into the model in 2023. Coupled with that, we will understand how data governance enhances data quality, consistency, and compliance while supporting decision-making processes.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand the value of the DIA RIM Reference Model
  • Understand how data governance enhances data quality, consistency, and compliance while supporting decision-making processes
  • Gain insights into best practices of data governance for RIM, including data classification, ownership, privacy, and security measures, enabling participants to establish robust and compliant data management frameworks


D. Vanessa  Brewer-Yizar

Test Driving the DIA RIM Reference Model

D. Vanessa Brewer-Yizar

Gan & Lee Pharmaceuticals Corp. US, United States

Manager, Global Regulatory Affairs

John  Jones, MBA


John Jones, MBA

EntiTech Solutions, United States

Chief Executive Officer

Michael  Smart, MBA

Value of and approach to Data Governance for RIM

Michael Smart, MBA

Astrix Technology Group LLC, United States

Sr. Director Customer Success

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