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Tuesday, September 8 • 11:15am - 12:00pm
Are You Adoption of Quality-by-Design and Risk-based Quality Management Approaches Improving Clinical Trial Quality?
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Keynote: working title (to be finalized by FDA)
Are You Adoption of Quality-by-Design and Risk-based Quality Management Approaches Improving Clinical Trial Quality?
  • What is FDA seeing when conducting inspections of studies that used risk- based quality management approaches? Is quality improving?
  • What should clinical research industry stakeholders keep in mind when implementing quality-by-design and risk-based quality management programs?
  • How is the FDA using data to quantify risk to determine where to conduct site inspections?
Jean Mulinde, MD
Policy Advisor
Division of Clinical Compliance Evaluation
Office of Scientific Investigations
CDER, FDA (INVITED)
Speakers
avatar for Jean Mulinde, MD

Jean Mulinde, MD

Policy Advisor, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, CDER, FDA
Dr. Jean Mulinde, Senior Advisor, Division of Clinical Compliance Evaluation, CDER, FDADr. Mulinde is currently the Senior Policy Advisor for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific... Read More →

Tuesday September 8, 2020 11:15am - 12:00pm PDT
MCC Virtual Platform
  General Session, Keynote