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Session Chair(s)
Craig A Wozniak
Head, Americas Clinical Operations
GlaxoSmithKline, United States
Learning Objective : Discuss the methodology developed by TransCelerate members for quality risk management and risk-based monitoring implementation; Describe the processes, tools and operational considerations for implementation of this approach.
Speaker(s)
TransCelerate: Overview of Organization and Risk-based Monitoring Methodology
Craig A Wozniak
GlaxoSmithKline, United States
Head, Americas Clinical Operations
Pilot Implementation: Practical Experience to Date
Michael B. Luker, MBA
Eli Lilly and Company, United States
Senior Advisor
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