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Regulatory Submissions, Information, and Document Management Forum

Session 7 Track 1: New Developments in RIM Reference Model

Session Chair(s)

Vahe  Ghahraman, PhD

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


Venkatraman  Balasubramanian, PhD, MBA

Progress Report on RIM Reference Model and Applications

Venkatraman Balasubramanian, PhD, MBA

  • SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
  • Orion Innovation, United States
Donald  Palmer, MA


Donald Palmer, MA

  • Senior Regulatory Affairs Director; Business & Technology Transformation
  • IQVIA, Inc., United States
John  Jones, MBA


John Jones, MBA

  • Chief Executive Officer
  • EntiTech Solutions, United States
Donna  Yosua


Donna Yosua

  • Director, InforMaster Data Management & Data Governance
  • Merck & Co., Inc, United States
Patterson  Shafer


Patterson Shafer

  • Managing Director
  • FTI Consulting, Inc., United States