DIA Regulatory Information Management eBOOK NOW AVAILABLE
We are thrilled to announce the release of the eBook, "Achieving Excellence in Regulatory Information Management," published by the Drug Information Association (DIA). Our Managing Partner, Cary Smithson, was one of the authors; and we are excited to share this valuable resource with you. Over the past few years, the DIA Regulatory Affairs Community Regulatory Information Management (RIM) Working Group has dedicated countless hours to updating the original RIM consensus white paper. We have expanded on key topics, delving into areas such as regulatory intelligence, artificial intelligence and automation, to provide you with the most comprehensive guide to RIM capabilities and functional interfaces. This eBook is a culmination of our efforts to bring you the latest trends and best practices in RIM. By learning from regulatory affairs experts, you will gain insights into new topics that are shaping the industry. Please provide your email address below for a link to the eBook.
Resources and Thought Leadership
Invitation to Contribute Ideas to Reducing Regulatory Product Approval Timelines
Invitation to Contribute Ideas to Reducing Regulatory Product Approval Timelines
Invitation to Contribute Ideas to Reducing Regulatory Product Approval Timelines
We contributed as part of a panel of industry experts to the "Invitation to Comment: Warp-Speeding Regulatory Decisions" article in DIA Global Forum which invites you to provide your ideas to move the industry towards global simultaneous submissions and speed the approval of new products for patients.
This article relates to the workshops held at the 2025 DIA RSIDM Forum and again at the DIA Annual Meeting in June. JOIN US there or contact us to share your ideas or your interest in contributing to future white papers on the topic.
DIA RIM Reference Model
Invitation to Contribute Ideas to Reducing Regulatory Product Approval Timelines
Invitation to Contribute Ideas to Reducing Regulatory Product Approval Timelines
Our industry experts have contributed to the development of the DIA RIM Reference Model and related white papers since 2016. The Regulatory Information Management (RIM) Reference Model is a conceptual framework for RIM systems, data, and processes. The Reference Model is intended to aid organizations in structuring the complex organizational, data, process, information, and workflow issues as they implement or upgrade their RIM systems. Adopting the model simplifies data interoperability, compliance with data standards, and use of artificial intelligence and other advanced technologies.
Contact us for the latest model and implementation advice.
Article on Regulatory Digital Trends
DIA GMP Quality Systems Reference Model
DIA GMP Quality Systems Reference Model
Cary Smithson collaborated with her colleague Karl-Heinz Loebel on an article in BioProcess International to provide information on recent trends in regulatory information management, digitalization, and increased demand for artificial intelligence solutions, “Centralize, Modernize, Harmonize: The Acceleration of Regulatory Digital Trends,” March 2024.
DIA GMP Quality Systems Reference Model
DIA GMP Quality Systems Reference Model
DIA GMP Quality Systems Reference Model
We led the development of the DIA GMP Quality Systems Reference Model that provides a model of accepted practices across the pharmaceutical industry for the organization (taxonomy) and metadata properties of documentation required & recommended for Good Manufacturing Practices (GMP) and to support Quality Management Systems. Adoption of this model simplifies regulatory information management and the use of artificial intelligence and advanced technologies.
Contact us for implementation advice.