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Regulatory Submissions, Information, and Document Management Forum

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

Session Chair(s)

Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

  • Senior Vice President, Life Sciences
  • Orion Business 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

Speaker(s)

Cary  Smithson, MBA

Marketed Products RIM Process Mapping

Cary Smithson, MBA

  • Director, Digital Transformation & Management
  • Grant Thornton LLP, United States
Donald  Palmer, MA

RIM Reference Model: Investigational Products RIM Process Mapping

Donald Palmer, MA

  • Associate Director, RIM
  • Regeneron Pharmaceuticals, Inc., United States
Joel  Finkle

The Building Blocks of the RIM Information Model

Joel Finkle

  • Associate Director Offering Management Regulatory Innovation
  • IQVIA, United States