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Misconduct and Management of Serious or Continued Noncompliance: Differences, Similarities, and Building a World-Class Program
Session Chair(s)
Deborah A. Waltz, MS
Vice President, Global Compound Support, Quality Assurance
Takeda Pharmaceuticals International, Inc., United States
Risk-Based Monitoring and Fraud Detection in Clinical Trials
Learning Objective : Discuss current FDA compliance expectations for sponsors and investigators; Identify and differentiate between manageable/correctable noncompliance and serious or continued noncompliance and scientific misconduct; Provide strategies for appropriate management and escalation techniques.
Speaker(s)
Risk-Based Monitoring and Fraud Detection in Clinical Trials
Richard Zink, PhD
JMP Statistical Discovery, United States
Principal Research Statistician
Good Clinical Practices: A CDER Perspective
Faranak Jamali, MD
FDA, United States
Medical Officer, OSI, Office of Compliance, CDER
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