Regulatory Submissions, Information, and Document Management Forum

Life Sciences companies continue to strive towards effective management of regulatory information. Lack of a common industry reference model hampers investment in RIM solutions and capabilities, leading to delays, rework and in some cases, product recalls. Aligning on a common RIM Reference Model will allow development of capabilities and solutions that will drive speed, efficiency and compliance. The DIA RIM Working Group formed a sub-group to define a RIM Reference Model. This group (made of industry sponsors, product vendors and consulting companies) has been working towards developing the key RIM processes and information model. The objectives of the session are to present the approach in developing the RIM Reference Model and share key deliverables including: definition of functional stakeholders involved in each major process, information flows and inputs/outputs for each major process, high-level conceptual RIM-related information objects and relationships. We will open this session for larger audience participation in the form of round tables to benefit from everyone’s insights. The initial draft of the RIM Reference Model is expected to be released by Summer of 2020.