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Clinical Quality Management Systems in the New Millennium
Session Chair(s)
Deborah Driscoll, MS
Vice President, MRL Quality Assurance
Merck & Co., Inc., United States
This session will describe ongoing activities of a TransCelerate BioPharma workstream evaluating clinical quality management system (QMS). Panelists will discuss ongoing development of a concept paper describing a progressive clinical QMS framework designed to provide a consistent, streamlined, and proactive quality approach across all stages of clinical research.
Learning Objective : Discuss a quality approach to clinical quality management across all stages of clinical research.
Speaker(s)
FDA Perspective
Jean M. Mulinde, MD
FDA, United States
Associate Director, Division of Clinical Compliance Evaluation, OSI
Industry Perspective
Ann Meeker-O'Connell, MS
FDA, United States
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
Issue Management
Leslie Sam
Leslie Sam and Associates, LLC, United States
President
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