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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 7:00 PM - Feb 13, 2019 8:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 10: Track 3: Innovation in Regulatory Affairs

Session Chair(s)

Karen  McCarthy Schau

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 :
  • Define the current challenges with regulatory intelligence function
  • Recognize technology trends like RPA, AI, ML, NLP and Deep Learning that is impacting other industries as well as life sciences
  • Discuss application of such technology trends in the context of Regulatory Intelligence to drive Regulatory Strategy
  • Identify the building blocks of such a solution that can transform Regulatory Policy Intelligence function across the industry
  • Speaker(s)

    David  Gwyn, MBA

    Leveraging End-to-End RIM to Drive Innovation in Regulatory Affairs

    David Gwyn, MBA

    fme US, United States

    VP, Business Consulting Services

    Venugopal  Mallarapu, MS

    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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