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.
ABOUT THE SPEAKER
Head of Innovation and Chief Technology Officer
Kinapse - London
With 30 years of experience in the biopharma industry, John’s early career started in Regulatory Affairs and Regulatory Operations. He has held global leadership positions in R&D IT, IT Shared Services, and Chief Technology Officer roles and responsible for the delivery of major technology-enabled organizational transformations in Regulatory, Safety, Clinical, Medical Affairs, IT, and Global Business Services. These solutions have included Content Management, Publishing, Medical Information, Safety, CTMS, Business Intelligence, Business Process Management, NLP, NLG Machine Learning, and AI. John has worked for and with many of the Top 50 Biopharma companies throughout his career. He holds a BSc in Chemistry and an MBA from Warwick Business School.