It is estimated that Regulatory Affairs departments spend approximately 70% of their resources on lifecycle management activities (CMC changes, labeling updates, renewals, and annual/aggregate reports, etc.), yet regulatory technology has been traditionally focused on new submissions and silo capabilities.
In this webinar, guest presenter, John Cogan, Head of Innovation and Chief Technology Officer, Kinapse, will explore the current state of regulatory technology and how it is not fit for Lifecycle Management.
As new integrated systems of record suites emerge, John will highlight the need for a far-reaching, re-definition of “RIM” and how this new RIM paradigm needs to embrace digital and automation technologies, including master data.
John will also address the global RIM user experience and how to ensure effective lifecycle management and avoid regulatory compliance failures.