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Regulatory Submissions, Information, and Document Management Forum
Session 10 Track 2: Introducing DIA RIM Reference Model 1.0
Venkatraman Balasubramanian, PhD, MBA
- Senior Vice President, 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
- Managing Director
- Amex, United States
Vahe Ghahraman, PhD
- Sr. Director
- Apellis, United States
D. Vanessa Brewer-Yizar
- Manager, Regulatory Affairs Consultant
- SG Research International LLC, United States
Donald Palmer, MA
- Senior Regulatory Affairs Director; Business & Technology Transformation
- IQVIA, Inc., United States