Regulatory Submissions, Information, and Document Management Forum

Changes to Regulatory Information Management (RIM) processes and systems must be in sync with frequent changes in global regulatory requirements, which to date are managed in silos using obsolete approaches. How can organizations leverage innovative approaches such as regulatory requirements as a service, where the knowledge base is provided as a service and is continuously maintained and updated? As organizations embark on transformational changes to their RIM systems, they must begin with a thorough understanding of business processes and requirements and focus on critical success factors such as business process transformation, organizational design, and change management, in addition to innovative technologies. As new systems are being planned and implemented, it is also important to leverage referential standards that are being derived from the efforts of IDMP such as Substances, Products, Organizations, Referentials (SPOR). These standards are going to become the basis for a single source of truth for authorized medicinal products and substances that can be reused across various regulatory processes. This session will have a reputed panel of experts sharing their views on how organizations must focus on critical success factors to transform the RIM landscape.