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Hilton Baltimore Inner Harbor

Jan 27, 2025 7:30 AM - Jan 29, 2025 12:45 PM

401 W Pratt Street, Baltimore, MD 21201, USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Advance Rates End

DAYS

HOURS

MINUTES

SECONDS

Session 12: Mastering FDA’s New Draft Guidance: Optimizing Data Monitoring Committees in Clinical Trials

Session Chair(s)

Susan  Kindig, JD, MD

Susan Kindig, JD, MD

Prior Executive Director, Medical and Drug Safety

United States

Barbara  Hendrickson, DrMed, MD

Barbara Hendrickson, DrMed, MD

Clinical Associate, Pediatric Infectious Diseases

University of Chicago, United States

This session will provide an introduction and overview of the newly-released FDA Draft Guidance on Use of Data Monitoring Committees (DMC) in clinical trials. Valuable practical information will be provided to enable safety professionals to better evaluate DMC charters and support the implementation of DMCs. In addition, the potential use of DMCs in IND reporting decisions for anticipated events in the study population will be discussed.

Learning Objective :
  • Interpret the new FDA Draft Guidance published in Feb 2024, “Use of Data Monitoring Committees in Clinical Trials” (“DMC Draft Guidance”)
  • Describe common misconceptions of DMCs and best practices for training of DMC members
  • Illustrate how a DMC can effectively assist safety organizations in evaluation of potential safety signals in ongoing clinical trials

Speaker(s)

Keith  Verrett, JD

Speaker

Keith Verrett, JD

FDA, United States

Regulatory Counsel, Office of Medical Policy, CDER

Frank W. Rockhold, PhD, MSc

Speaker

Frank W. Rockhold, PhD, MSc

Duke Clinical Research Institute, Duke University Medical Center, United States

Professor of Biostatistics

Melvin Slaighter Munsaka, PhD, MEd, MS

Speaker

Melvin Slaighter Munsaka, PhD, MEd, MS

AbbVie, United States

Senior Director, Head Safety Statistics

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