White Paper

RIM Framework Interim Consensus White Paper
Sheila Mahoney-Jewels
Joel Finkle
Director, Regulatory Innovation & IDMP Strategy
V. “Bala” Balasubramanian
Cabeus, Inc.
Cary Smithson
Director, Digital Transformation & Management
Grant Thornton, LLP
Vahe Ghahraman
Senior Director, Global Regulatory Operations
Alexion Pharmaceuticals, Inc.
Bernie Coney
Head, Assay Content Development & Product Labeling
Siemens Healthineers

DIA Regulatory Affairs Community Regulatory Information Management (RIM) Working Group


ife Sciences organizations are increasingly facing several business challenges: an expanding global footprint, evolving regulatory requirements, dynamic partnership models, and rapidly evolving technology. Many organizations are realizing the importance of regulatory information as a corporate asset and hence improving and innovating how regulatory information is captured and utilized across the regulatory and pharmaceutical value chains, commonly referred as regulatory information management (RIM). Organizations, both sponsors and the vendors that serve them, have come up with organic solutions that are fit for specific purposes; however, the resulting systems are often not harmonized in approach or terminology which compounds the complexity associated with ownership, flow of data across the enterprise, interoperability, quality responsibility, and governance of regulatory data, or any form of collaboration/integration.

The Regulatory Information Management Working Group (RIMWG) of DIA’s Regulatory Affairs Community has identified potential benefits that could be captured from the development of a conceptual framework for Regulatory Information Management (RIM). Such a framework would aid organizations in structuring the complex organizational, informational, and technological issues germane to RIM’s myriad of challenges related to cross-functional global data identification, ownership, quality management, and maintenance. The ultimate goal is to enable RIM as a strategic corporate asset that will have direct impact on a sponsor’s profitable operations and, ultimately, on expediting delivery of needed treatments to patients.

Over a two-year period, the RIMWG has authored an Interim Consensus White Paper describing the evolution of the RIMWG’s discussions, debates, feedback, and decisions made by various global RIM stakeholders during framework development. The framework itself comprises the identification of RIM capabilities according to common themes, or “buckets”; an “RIM Elements” catalog (in process); and a data map that identifies data elements and determines how data flows through the organization and related systems (also in process). The key objective of this initiative is to define an “Ideal RIM State” along with a RIM Reference Model which collects process, data, and organizational constructs that both sponsors and vendors could use as a benchmark to compare their respective capabilities and offerings. Together, the collection of data and process flow recommends not a binding regulation, but rather a reference-able framework for that “Ideal RIM State” upon which organizations can begin to model and benchmark against. The intention here is to create a framework which could benefit sponsor organizations, as well as technology and service providers, in their effort to improve how we manage regulatory information as a corporate asset.

While RIM has broader reach and scope, this interim consensus white paper starts by addressing key RIM components that are traditionally understood as “in-scope” for RIM. Many topics such as correspondence and commitments, labeling, and advertising and promotion, are not included in this version of the white paper. However, as the paper evolves, we will be adding more comprehensive definitions and other components. We expect this to be a “living document” that will continue to live until it covers all components included within the scope of RIM. We welcome broader industry participation and the expertise of individuals willing to join our efforts as volunteers to further the cause of this working group and contribute to the creation of artifacts to benefit industry.

Key stakeholders from this RIMWG will be conducting a round table at the Regulatory Submissions, Information, and Document Management (RSIDM) Forum from 7:30 – 8:30AM on February 12 in Bethesda, Maryland. We welcome participation from the regulatory community at large: Join us at RSIDM and make your voice heard by providing input into the RIM Elements Catalog, data map, and the evolving white paper.