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Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum
Session Chair(s)
Gerrit Hamre, MA
Research Director
Duke-Margolis Institute For Health Policy (DMI), United States
This forum will focus on practical Quality by design (QbD) and risk-based monitoring (RBM) clinical trial implementation strategies based on new case study examples of overcoming persistent adoption challenges, fostering organizational change management, and demonstrating value of implementation.
Learning Objective : Apply practical QbD-RBM implementation strategies based on case study examples not previously publicly presented; Learn of new initiatives under development that will serve as additional future QbD tools; Identify persistent obstacles to broader QbD and RBM implementation, address their negative impacts, and provide applicable solutions to enable future adoption.
Speaker(s)
Existing Adoption Tools for All to Use
Morgan Hanger, MPA
Clinical Trials Transformation Initiative (CTTI), United States
Executive Director
Evidence of the QbD-RBM Continuum in Action
Marion Wolfs, MS
Johnson & Johnson, Netherlands
Associate Director Risk Management & Central Monitoring
Agency Supporting Mechanisms for Clinical Trial Modernization
Representative Invited
FDA, United States
New Case Study Examples for Others to Build Upon
Sameera Ibrahim
Bristol Myers Squibb, United Kingdom
Head of Risk Governance & Operations, R&D Quality
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