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


  • Mary  Arnould, BSN, MSN

    Mary Arnould, BSN, MSN

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

    Mary has been in the pharmaceutical industry for over 20 years. She began her career as a site monitor and monitored studies in numerous therapuetic areas. Mary managed site monitors for over 10 years. She has been supporting the implementation of Risk Based Monitoring at Bristol Myers Squibb on a full time basis since October of 2014 focusing on site monitor execution. Mary is regionally based in Indianapolis, IN.

  • 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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