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Archive: Implications of the FDA Guidance for a Risk-Based Approach to Monitoring and EMA Reflection Paper Risk-Based Quality Management in Clinical Trials

December 14, 2018

Course Description

FDA and EMA have communicated their expectations for trial oversight/ monitoring, monitoring systems, and investigative site oversight. These are described in the FDA Guidance Oversight of Clinical Investigations: A Risk- Based Approach to Monitoring and the EMA Reflection Paper on risk-based quality management in clinical trials, both of which will be reviewed in this web seminar, as well as industry think tank contributions.

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Learning Objectives

  • Discuss the FDA Guidance and EMA Reflection Paper for clinical trial risk management and monitoring
  • Evaluate industry think tank trends (TransCelerate, CTTI)
  • Review best practices for risk management for trial oversight and monitoring

Who Should Attend

  • Clinical Investigators and Staff
  • Clinical Research Associates
  • Study and Clinical Research Associate Managers
  • Sponsors/CROs Clinical Operations
  • Clinical Quality Compliance and Quality Assurance Professionals


Elizabeth Ronk Nelson, MPH

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.