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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; Discuss 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)
Evidence of the QbD-RBM Continuum in Action
Mike Jacobs
Bristol Myers Squibb, United States
Senior Director, Study Optimization & Assessment Planning
Existing Adoption Tools for All to Use
Morgan Hanger, MPA
Clinical Trials Transformation Initiative (CTTI), United States
Executive Director
Agency Supporting Mechanisms for Clinical Trial Modernization
Alissa Mun, MS
FDA, United States
Health Scientist Policy Analyst, OMP, CDER
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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