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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
Associate Director, Division of Clinical Compliance Evaluation, OSI, FDA, United States
Industry Perspective
Ann Meeker-O'Connell, MS
Executive Director, Monitoring Excellence Head, Novartis, United States
Issue Management
Leslie Sam
President, Leslie Sam and Associates, LLC, United States
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