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Regulatory Submissions, Information, and Document Management Forum

Session 9: Track 2: Transforming Regulatory with Digital Technologies

Session Chair(s)

Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

  • Senior Vice President, Life Sciences
  • Orion Business Innovation, United States
This session will explore the use of digital technologies including AI and ML in regulatory, especially in the areas of regulatory operations, submissions management, and archiving, among others. It will cover potential use cases to improve compliance, efficiency and automation, as well as an action plan to implement AI and ML within regulatory.
Learning Objective : Upon completion of this session, the participant should be able to:
  • Identify digital technologies that are available and potential use cases with regulatory affairs
  • Review how artificial intelligence and machine learning can complement regulatory management in the future
  • Create plans for the implementation of AI and ML in regulatory operations, especially around submissions management and archiving
  • Speaker(s)

    Scott  Cleve

    Exploring Digital Technology in Regulatory Affairs

    Scott Cleve

    • Head of Global Regulatory Operations
    • Boehringer Ingelheim, Germany
    Brian  Burke-Green, MSc

    Introducing AI and Automation with Submission

    Brian Burke-Green, MSc

    • Regulatory Manager
    • Pfizer, United States
    Rob  Connelly, MBA

    The Compliment of AI within Life Science

    Rob Connelly, MBA

    • Executive Director, Product Development
    • Synchrogenix, A Certara Company, United States