Back to Agenda
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)
Anabela Marcal, PHARMD
EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
EU Regulatory Perspective
Ann Meeker-O'Connell, MS
Executive Director, Monitoring Excellence Head, Novartis, United States
US Regulatory and Sponsor Perspective
Coleen Glessner, MBA
Senior Vice President, Chief Quality Officer, Alexion Pharmaceuticals, United States
Large Sponsor Perspective
Brian Hagen
Managing Director, Decision Empowerment Institute, United States
How Can Decision Analytic Techniques Be Used Within Clinical Trial Settings?
Have an account?