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Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives
Session Chair(s)
Junko Sato, PHD
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Poor study management, misconduct, and data falsification threaten regulatory decisions on product safety and efficacy. This session will cover regulatory guidelines and case studies of clinical trial electronic systems, risk assessment strategies.
Learning Objective : Describe regulatory expectations for electronic systems in clinical trials, including electronic health records (EHRs); Examine criteria for evaluating whether these systems are suitable for trials; Discuss methods for identifying and mitigating fraud and misconduct risks in these systems; Identify case studies of fraud and mismanagement to emphasize the need for thorough risk assessments.
Speaker(s)
How to Combat Fraud?
Kentaro Ichinose
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Inspector
FDA Perspective
Regina Zopf, MD, MPH
FDA, United States
Senior Medical Officer, CDER
MHRA Perspective
Jason Wakelin-Smith
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Expert GCP Inspector & Head of Compliance Expert Circle
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