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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don’t miss the latest conversations in RIM, EDM, and ERS! Join your industry colleagues and regulatory thought leaders and register for the Regulatory Submissions, Information, and Document Management Forum.

Session 6 Track 1: RIM Reference Model: 2019 Progress/Call for Engagement

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. Lack of a common industry reference model hampers investment in RIM solutions and capabilities, leading to delays, rework and in some cases, product recalls. Aligning on a common RIM Reference Model will allow development of capabilities and solutions that will drive speed, efficiency and compliance. The DIA RIM Working Group formed a sub-group to define a RIM Reference Model. This group (made of industry sponsors, product vendors and consulting companies) has been working towards developing the key RIM processes and information model. The objectives of the session are to present the approach in developing the RIM Reference Model and share key deliverables including: definition of functional stakeholders involved in each major process, information flows and inputs/outputs for each major process, high-level conceptual RIM-related information objects and relationships. We will open this session for larger audience participation in the form of round tables to benefit from everyone’s insights. The initial draft of the RIM Reference Model is expected to be released by Summer of 2020.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Share progress on the RIM Reference Model by the DIA RIM Working Group
  • Seek input from the audience on the work accomplished so far
  • Incorporate audience input into the RIM Reference Model


Donald  Palmer, MA

RIM Reference Model: Investigational Products RIM Process Mapping

Donald Palmer, MA

United States


Cary  Smithson, MBA

Marketed Products RIM Process Mapping

Cary Smithson, MBA

Cencora Pharmalex, United States

Senior Director, Business Transformation & Systems Management

Joel  Finkle

The Building Blocks of the RIM Information Model

Joel Finkle

Retired, United States

Industry Expert

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