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Approaches to Quality Risk Management: Understanding What Matters
Session Chair(s)
Martin Landray, PhD, FRCP
Chief Executive
Protas, United Kingdom
This forum will review the Clinical Trials Transformation Initiative’s (CTTI) potential methods to apply principles of Quality by Design and quality risk management to the scientific and operational design of clinical trials.
Learning Objective : Discuss the workshops on quality risk management; Describe general principles for building quality into the design of trials; Identify benefits and obstacles to the adoption of this approach based on feedback from CTTI workshop participants.
Speaker(s)
What Are the Key Drivers for Quality?
Martin Landray, PhD, FRCP
Protas, United Kingdom
Chief Executive
Quality Risk Assessment and Quality by Design: Principles Not Jargon
Mark Behm
Astrazeneca, United States
Sr Director Procedural Quality
Regulatory Requirement for Ensuring Quality: A US Perspective
Ann Meeker-O'Connell, MS
FDA, United States
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
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