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Session 7 Track 1: New Developments in RIM Reference Model
Session Chair(s)
Vahe Ghahraman, PhD
Senior Director, Global Regulatory Operations Head
Apellis Pharmaceuticals, Inc. , United States
DIA RIM-WG sub team on RIM Reference Model has been working on establishing a process-centric reference model for quite some time. In this session, the team will present a simpler (object-centric) version of the model. The primary objective of the latest update is to make the model easy to understand, adopt and implement by sponsors, vendors, and system integrators alike. A sponsor will also provide updates on ongoing work related to their product hub use case/application, leveraging elements of the RIM Reference Model. We will also discuss a case study of where the RIM reference model is aligning and helping to shape the creation of a large initiative to share RIM data not only within regulatory but to other departments as well. The case study will discuss elements such as data security, governance, quality, and self-service reporting. Updates on other related activities including RIM whitepaper (V3) and collaboration with other organizations and initiatives (Pistoia & Accumulus) will also be provided.
Learning Objective : - Understand updates to the RIM Reference Model
- Make aware of new content in V 3.0 of RIM Whitepaper
- Application of the RIM Reference model to create an integrated view of product data
- Understand how the RIM reference model can be put to practical use for organizational data sharing and reporting
Speaker(s)
Progress Report on RIM Reference Model and Applications
Venkatraman Balasubramanian, PhD, MBA
VB Insights, LLC, United States
Healthcare and Life Sciences Advisor
Speaker
Donald Palmer, MA
United States
Consultant
Speaker
John Jones, MBA
EntiTech Solutions, United States
Chief Executive Officer
Speaker
Donna Yosua
Merck & Co., Inc, United States
Director, Master Data Management & Data Governance
Speaker
Patterson Shafer
FTI Consulting, Inc., United States
Managing Director
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