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DIA 2018 Global Annual Meeting


Building a Roadmap to the Implementation of the Risk-Based Monitoring Process: Facilitating the Perspectives of All Stakeholders

    Session Chair(s)
      Mary  Banach, PhD, MPH

      Mary Banach, PhD, MPH

      • Project Manager CTSpedia
      • Vanderbilt University, United States
    This workshop will allow attendees to look at terms defined by regulatory authorities and to compare and contrast the understanding of risk-based monitoring (RBM) from the perspectives of the various stakeholders. We will use practical examples.

    The DIA CDM and RBM Communities have been working on a project that creates a concrete ‘Roadmap’ for companies on how to implement ‘RBM’ - or more generally how to implement a data backbone in the organization that would allow the different functions (data management, pharmacovigilance, medical monitoring, operations, regulatory, etc.) to leverage the appropriate data collected/generated by CDM and other functions as indicators to identify critical risks in their specific area.
    Learning Objective : Define risk-based monitoring (RBM) from different stakeholders’ perspectives: data management, pharmacovigilance, medical monitoring, operations, and regulatory; Compare and contrast terms used in RBM from different stakeholders’ perspectives; Review the major difficulties encountered in each phase of developing an RBM program.
    Speaker(s)
      Stephen  Young, MSc

      Where We Are: Where We Are Going

      Stephen Young, MSc

      • Chief Operations Officer
      • CluePoints, United States
      Nimita  Limaye, PhD

      Vendor Selection for Risk-Based Monitoring

      Nimita Limaye, PhD

      • Chief Executive Officer
      • Nymro Clinical Consultancy Services, India