Regulatory Submissions, Information, and Document Management Forum

In today’s current state, data and many procedures are bound by functional silos, and while the data collected and the existing processes might be considered optimized within their individual domains, to truly achieve breakthrough improvement, optimization of data and processes must be achieved across the enterprise and beyond these individual domains. Many of these business needs already exist, including the need to measure time from safety signal to implementation of an updated label, or having the ability to run reports specific to combining regulatory authorization and marketing information.

Key to solving these challenges is leveraging standards (like the RIM Reference Model, open APIs) that allow for more consistent and seamless flows of information in and around the ‘regulatory Information' that sits at the middle of the equation. That along with being able to define business processes and & information capture needs in a repeatable, consistent and automated fashion will support operational excellence as well as greater information traceability.

Working to break down silos and having data flow across many domains will lead to business value including seeing measurable improvement across the end-to-end submission process, implementation of manufacturing improvements by implementing changes closer to the time of health authority (HA) approval, and drive efficiency with release of product to patients. In this session, we will discuss how establishing a road map for creating rules for master data, empowering Business Process Owners to work cross-functionally and connecting authoritative sources for information across the enterprise will eliminate unnecessary hand-offs, will reduce cycle times, and will improve compliance to regulations.