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Embracing ICH E6(R3) with Risk-Based Quality Management
Session Chair(s)
Madeleine Whitehead
RBQM CoE - Head
Roche, United Kingdom
Through use cases and maturity models, this session will focus on strategies and barriers to integrating RBQM in clinical trials.
Learning Objective : Interpret key changes in ICH E6(R3) regarding RBQM and data governance; Implement key principles, components, and change management strategies for RBQM; Assess and benchmark organizational adoption of RBQM components.
Speaker(s)
Navigating the Future of Clinical Trials: Embracing ICH E6(R3) with Risk-Based Quality Management
Nicole Stansbury
Premier Research, United States
Senior Vice President Global Clinical Operations
New and Expanded Assessment of Risk-Based Quality Manangemnt Adoption: Assessing Implementation Progress and Impactased
Abigail Dirks, MS
Tufts Center for the Study of Drug Development, United States
Data Scientist
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