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Quality Risk Management: An Old Hat?
Session Chair(s)
Beat Widler, PHD
Co-Founder and Vice President, ACRES; Managing Director
Widler & Schiemann AG, Switzerland
A risk-based approach to quality management in clinical trials is the obvious solution. However, many sponsors of clinical trials have attempted it and failed. This session will show the essentials and examples of a successful implementation.
Learning Objective : Discuss how to plan for and make a risk-based approach to quality management work in their environment; Describe what needs to be considered when implementing a risk-based quality management approach; Identify the challenges that need to be overcome for successful implementation.
Speaker(s)
QRM: Connecting the Operational Dots
Beat Widler, PHD
Widler & Schiemann AG, Switzerland
Co-Founder and Vice President, ACRES; Managing Director
QRM: Tipping the Scales Towards Success – The Change Management Story
Brian J. Nugent, BSN, RN
Gilead Sciences, Inc., United States
Associate Director, Clinical Operations
Key Quality Indicators (KQIs): What are They? How Are They Being Used in Risk-based Monitoring Approaches?
Linda B Sullivan, MBA
Tufts Center For the Study of Drug Development, United States
Senior Fellow