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#306: Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives
Wednesday June 18, 2025 8:30am - 9:30am EDT
152AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-614-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Junko Sato, PhD

Speaker

How to Combat Fraud?
Kentaro Ichinose

FDA Perspective
Regina Zopf

MHRA Perspective
Jason Wakelin-Smith


Speakers
KI

Kentaro Ichinose

Inspector, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Kentaro Ichinose currently serves as a inspector of the Office of Non-clinical and Clinical Compliance I in the Pharmaceuticals and Medical Devices Agency (PMDA).
avatar for Junko Sato

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →
RZ

Regina Zopf

Senior Medical Officer, CDER, FDA, United States
Wednesday June 18, 2025 8:30am - 9:30am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   02: ClinTrials-Ops, Session

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