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Quality and Risk Management in an Increasingly Complex Clinical Research Environment: State of the Industry and Leading Practices
Session Chair(s)
Patty Leuchten
Founder and CEO
Diligent Pharma, United States
Data from a recent quality consortium assessment, a collaboration focused on proactive quality management, will serve as a catalyst for interactive audience discussion. The focus will be on managing quality, decision making, and mitigating risk.
Learning Objective : Describe the challenges of current quality and risk management approaches; Explain decision methodologies for identifying and mitigating risk; Discuss how companies can address challenges of complexity in decision-making and risk mitigation; Identify strategies for improving the return on investment for proactive quality and risk management practices.
Speaker(s)
EU Regulatory Perspective
Anabela Marcal, PharmD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
US Regulatory and Sponsor Perspective
Ann Meeker-O'Connell, MS
FDA, United States
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
Large Sponsor Perspective
Coleen Glessner, MBA
Alexion Pharmaceuticals, United States
Senior Vice President, Chief Quality Officer
How Can Decision Analytic Techniques Be Used Within Clinical Trial Settings?
Brian Hagen
Decision Empowerment Institute, United States
Managing Director
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