Description: As regulatory organizations face increasing volume, complexity, and global expectations, legacy RIM systems and document-centric processes are no longer sufficient. Modern RIM is foundational to regulatory data strategy—enabling structured content, traceability, submission readiness, and real-time insights across the product lifecycle. This roundtable will bring together regulatory affairs and regulatory operations professionals to discuss practical approaches to RIM modernization.
Participants will share experiences navigating RIM transformations, including replacing or optimizing legacy platforms, defining data models and governance, integrating RIM with submission, quality, and enterprise systems, and managing organizational change. The discussion will focus on lessons learned, common pitfalls, and incremental strategies that deliver value while minimizing disruption—helping teams move toward scalable, data-driven regulatory operations.
Learning Objectives:
Identify key drivers and success factors for RIM modernization, including data standards, governance models, and alignment with regulatory business processes
Compare real-world approaches to modernizing or optimizing RIM platforms, addressing challenges such as legacy data migration, system integration, and user adoption
Define practical, phased next steps to advance RIM maturity and enable data-driven regulatory operations, analytics, and automation
