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Tuesday, September 28 • 1:00pm - 1:30pm
TRACK A: Critical To Quality Factors

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Evaluate Risks to Ensure The Focus is Only On The Quality Issues That Matter
  • Understand the elements of the protocol that are critical and impact subject safety and/or data integrity
  • Evaluate the risks related to those identified critical processes and data
  • Identify risks on both the system and trial levels
  • Describe how to effectively document this identification process 

avatar for Maria Weber

Maria Weber

Director, Risk Evaluation and Adaptive Integrated Monitoring, MERCK
avatar for Patrice Benner

Patrice Benner

Director, Risk Evaluation and Adaptive Monitoring (REAIM), MERCK
Over 20 years of Project Management, Data Management, and Clinical Trial Operations experience within pharma across multiple therapeutic areas including Vaccines, Infectious Disease and Neuroscience.  Passionate about patient safety, quality and risk evaluation, spending the last... Read More →

Tuesday September 28, 2021 1:00pm - 1:30pm EDT