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Archive: Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA

Course #: BI14880
February 16, 2022

Course Description

The FDA and EMA describe their expectations for risk-based approaches to quality management and monitoring 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 are reviewed in this web seminar, which also includes 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


Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Click here for complete trainer biographies


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