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DIA eBooks

DIA eBook: Achieving Excellence in Regulatory Information Management

Achieving Excellence in Regulatory Information Management

The original RIM white paper was released in October 2019. Since then, members of the DIA Regulatory Affairs Community, working in Regulatory Information Management (RIM), have continued to update this paper as the field has evolved. The original version focused on several key topics relating to core RIM capabilities. White paper 2.0 kept pace with industry thinking, expanding to new topics such as regulatory intelligence and automation.

Over the last several years, the white paper team has increased breadth and depth to bring you a complete 3.0 publication in the form of best practices across the spectrum of RIM capabilities and functional interfaces.

eBook Price: $35.00

Purchase your eBook copy today!

Sample Hot Topics Included in eBook

Clinical Development & Operations

Drug / device combinations

Helping regulatory drug teams understand the expectations of the Center for Devices and Radiological Health, MDR and other device topics

Data & Data Standards

Intelligent Automation

Exploring use cases, in development and in use - to enhance regulatory performance

Project Management & Strategic Planning

Functional Intersections

Exploring the important connections across the enterprise to streamline process, accelerate submissions and improve compliance


RIM Reference Model

Introduction to RIM Reference Model with entities, relationships, and the data attributes

DIA would like to thank its sponsors of this publication:

DIA Sponsor: Gold


FTI Consulting

Orion Innovation

DIA Sponsor: Bronze



Patterson Shafer


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