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Session 8 Track 2: The Value of Reference Models and Data Governance for RIM
Session Chair(s)
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
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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
Speaker(s)
Test Driving the DIA RIM Reference Model
D. Vanessa Brewer-Yizar
Gan & Lee Pharmaceuticals Corp. US, United States
Manager, Global Regulatory Affairs
Speaker
John Jones, MBA
EntiTech Solutions, United States
Chief Executive Officer
Value of and approach to Data Governance for RIM
Michael Smart, MBA
Astrix Technology Group LLC, United States
Sr. Director Customer Success