×
Back to Agenda
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)
Nicole Stansbury
Senior Vice President Global Clinical Operations, Premier Research, United States
Navigating the Future of Clinical Trials: Embracing ICH E6(R3) with Risk-Based Quality Management
Abigail Dirks, MS
Senior Data Scientist, Tufts Center for the Study of Drug Development, United States
New and Expanded Assessment of Risk-Based Quality Manangemnt Adoption: Assessing Implementation Progress and Impactased
Have an account?