The purpose of a Regulatory Information Management system (RIMS) is to consolidate regulatory information into one place to enable the tracking and management of registrations. This has been the same challenge for over twenty years; replacing spreadsheets and bespoke databases, and is still very pertinent today. Regulatory Information Management is the third part of the Document Management and Regulatory Publishing triptych. These systems are intrinsically linked, sharing documents and data within a regulatory ecosystem. Today we are seeing further momentum in the transformation of filing data and documents in unison, as structured product registrations to Health Authorities, in addition to more complex internal processes to codify and track global regulatory information. In this presentation we will explore the benefits of a state-of-the-art end-to-end regulatory information management platform. We will see what is desirable and what is practical in 2022.
Learning Objectives:
Review the purpose of a Regulatory Information Management platform
Illustrate the inter dependencies and linkages between a RIM platform components
Identify the efficiency benefits and the ways a state-of-the-art RIMS platform can transform
Regulatory Affairs.