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Session 10: Track 3: Innovation in Regulatory Affairs
Session Chair(s)
Karen McCarthy Schau
Director, Risk-based Study Management
Vertex Pharmaceuticals, United States
In the last three to five years, application of technology trends like Robotic Process Automation, Artificial Intelligence, Natural Language Processing, and Deep Learning has increased gradually in other industries as well as in life sciences. Additionally, Life Sciences organizations today are focused on addressing an increasing number of regulatory requirements which span across geographies, business activities and functions. These presentations will introduce the audience to these trends, discuss their application more broadly across various industries, and make a case on how application of such technologies could benefit regulatory affairs tremendously and drive innovation. Regulatory affairs function is key to improving document management, along with the process controls associated with regulatory submissions that increase efficiencies of the entire product development value chain and reduce time-to-market. This knowledge can be leveraged by sponsors and vendors in revisiting their Regulatory Intelligence Platform strategy and potentially undertake pilots and business cases in investing further to drive programs in their organizations.
Learning Objective :
Speaker(s)
Leveraging End-to-End RIM to Drive Innovation in Regulatory Affairs
David Gwyn, MBA
fme US, United States
VP, Business Consulting Services
Building Next Generation Regulatory Intelligent Platform Using Innovative Technologies Like Automation, AI, and Deep Learning
Venugopal Mallarapu, MS
Cognizant, United States
Senior Director and Global Head of Life Sciences R&D
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