Regulatory Submissions, Information, and Document Management Forum

The RIM Reference Model Working Group core team was formed in February 2019 to begin work on defining and building a baseline data/information model in order to address common needs of sponsors and support effective implementation of Regulatory Information Management (RIM) solutions. The objective has been to enable regulatory and other functional areas to have better line of sight of regulatory activities and related information by defining component objects/concepts and relationships as well as common terminology. Such common terminology will not only be the basis for a “starter kit” for organizations looking to bootstrap their RIM initiatives from a user requirements perspective but also form the basis for interoperability, a template for potential RFPs and data exchange in a mergers and acquisition scenario. An extended team was formed at the RSIDM 2020 roundtable session, with representation from drug sponsors, software vendors and service providers. A draft version of a Reference Model was developed and shared at RSIDM 2021. Since then, the RIM Working Group has further developed the model, shared with industry sponsors/vendors and received feedback.

This complimentary workshop will feature a recap of the RIM Reference Model structure and content along with feedback received from the industry. A live demonstration of the model will show how “objects and data elements” relate to regulatory activities and regulatory objectives. The team will also present a validation exercise using CMC Variation as an example to validate the proposed reference model data elements. The intent of this session is to encourage industry and vendor participation to further validate the work done so far and also uncover any opportunities for the use of intelligent automation in support of the CMC Variation process. At the end of this exercise, the team is looking to formally release Version 1.0 of the Reference Model for industry/vendor use.

In addition, there will be an update by the DIA RIM AI Working Group regarding progress made by the group around AI use cases and call for industry participation.