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Session 0106: RISK BASED APPROACH TO CLINICAL TRIALS
Session Chair(s)
Qing Zuraw, MD, MBA
Covance, Inc., United States
The application of Risk-Based Monitoring (RBM) is a hot topic across the industry. How to better understand and implement regulatory guidance and what is the applicability to trial conduct in China? This session will discuss how to increase risk awareness, take appropriate monitoring approaches, and manage quality for clinical studies.
Speaker(s)
Risk-Based Quality Management in Clinical Trials: A Risk Proportionate Approach
David Cockburn
European Medicines Agency, Netherlands
Head of Manufacturing and Quality Compliance Service
Risk-Based Monitoring from the Global Perspectives
Qing Zuraw, MD, MBA
Covance, Inc., United States
Jane LIN, MD
Johnson & Johnson Medical (China) Ltd., China
VP, Strategic Medical Affairs
Shuting Li, MD
GCP Alliance, China, China
Deputy Director
Risk-Based Monitoring Current Practice & Challenges
Yanxia Huang
MSD R&D (China) Co., Ltd, China
Asso. VP, Clinical Research
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