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#34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model


  • Mary  Arnould

    Mary Arnould

    • Director, Clinical Science Operations
    • Astellas Pharma Global Development, Inc., United States

    Mary is Director, Clinical Science Operations and RBM Lead at Astellas. Her pharmaceutical career spanning over 25 years has included site monitoring, site monitoring management, development of technology and process solutions for site monitoring execution and leading RBM implementation efforts. She has been involved in RBM implementation at two pharma companies focusing on process refinement, technology deployment, and change management.

  • Cecilie  Freddie Lange

    Cecilie Freddie Lange

    • RBM Specialist
    • Novo Nordisk A/S, Denmark

  • Stuart  Shaw

    Stuart Shaw

    • Risk Based Quality Management Project Leader
    • Boehringer Ingelheim Pharmaceuticals Inc., United States

    Stuart has over 20 years pharmaceutical experience within Biometrics and Data Management. He has contributed to many regulatory submissions and inspections during this time. Stuart has been working on the implementation of Risk Based Monitoring at Boehringer Ingelheim since 2013 and assumed responsibility as the global lead of this project in 2016. Stuart currently resides in Connecticut.

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