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Feb 08, 2021 10:00 AM - Feb 10, 2021 4:30 PM

(Eastern Standard Time)

Regulatory Submissions, Information, and Document Management Forum

Session 10 Track 2: Introducing DIA RIM Reference Model 1.0

Session Chair(s)

Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences

Orion Innovation, United States

Life Sciences companies continue to strive towards effective management of regulatory information. The industry has recognized the need for defining a baseline information model so everyone can embrace it, to develop RIM capabilities that improve efficiencies, ensure compliance and enable interoperability among systems. During RSIDM 2020, members of the DIA RIM Working Group provided an overview of the RIM Reference Model and sought broader industry engagement. The model has been developed further this year along with input from industry sponsors, product vendors, system integrators and consulting companies. During this session, we will be introducing Version 1.0 of the Reference Model, which includes high-level data specifications on key information constructs which form the foundation for RIM including data definitions, representative values, controlled vocabularies, sources of regulatory information, consumers of regulatory information and metrics for eight key regulatory processes.
The session is designed as a panel with subject matter experts from the RIM Reference Model Working Group presenting key deliverables (information flows, information objects and relationships) and discussing how the model can help companies achieve their RIM objectives and ultimately improve overall speed, efficiency and compliance.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Introduce the RIM Reference Model Version 1.0 with underlying information constructs and data elements/relationships
  • Validate RIM reference model with potential implementations
  • Identify implementation opportunities and risks


Patterson  Shafer


Patterson Shafer

FTI Consulting, Inc., United States

Managing Director

Vahe  Ghahraman, PhD


Vahe Ghahraman, PhD

Apellis Pharmaceuticals, Inc. , United States

Senior Director, Global Regulatory Operations Head

D. Vanessa  Brewer-Yizar


D. Vanessa Brewer-Yizar

Gan & Lee Pharmaceuticals Corp. US, United States

Manager, Global Regulatory Affairs

Donald  Palmer, MA


Donald Palmer, MA

United States


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