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Thursday, July 1 • 10:00am - 11:00am
#407 SL: Reliability of Data Results in Clinical Trials (ICH E6 (R2)): What Does it Mean and How Can it be Accomplished?

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-636-L04-P; CME 1.00; IACET 1.00; RN 1.00

The purpose of this session is to delve into the meaning behind the ICH E6 (R2) goal of “reliability of data” and to present methods to measure, monitor, and improve the reliability of clinical trials and their component processes.

Learning Objectives

Describe the ICH E6 (R2) guidance that states a sponsor must “ensure the reliability of study results”; Discuss how to improve the reliability and accuracy of clinical trial data through the application of scientific principles.

Chair

Nathaniel P. Katz, MD, MS

Speaker

FDA Update
Jean M. Mulinde, MD

Reliability of Data Results in Clinical Trials
Emanuel S Troullos, DDS, MPH


Speakers
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI, FDA, United States
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Nathaniel Katz

Nathaniel Katz

Chief Science Officer, WCG Analgesic Solutions, United States
Dr. Katz is a pain physician and Chief Science Officer at WCG Analgesic Solutions, a specialty consultancy and clinical research center focused on analgesic drug development. Dr. Katz also previously Chaired the advisory committee to the Anesthetics division of FDA.
ET

Emanuel Troullos

Global Medical Affairs, Contract Employee, Belcan, United States
Emanuel Troullos, DMD, MPH, retired from Bayer Healthcare in 2020. His career spanned over 30 years in the clinical research and medical affairs divisions of several pharmaceutical companies. Presently, he is employed by Belcan as a part time contract employee on assignment to Ba... Read More →

Thursday July 1, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session |   08: RD Quality-Compliance, Session |   02: ClinTrials -ClinOps, Session