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Embracing ICH E6(R3) with Risk-Based Quality Management
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Through use cases and maturity models, this session will focus on strategies and barriers to integrating RBQM in clinical trials.

Learning Objectives

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.

Chair

Madeleine Whitehead

Speaker

Navigating the Future of Clinical Trials: Embracing ICH E6(R3) with Risk-Based Quality Management
Nicole Stansbury

New and Expanded Assessment of Risk-Based Quality Manangemnt Adoption: Assessing Implementation Progress and Impactased
Abigail Dirks, MS


Speakers
AD

Abigail Dirks

Data Scientist, Tufts Center for the Study of Drug Development, United States
Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative site... Read More →
avatar for Nicole Stansbury

Nicole Stansbury

Senior Vice President Global Clinical Operations, Premier Research, United States
Nicole Stansbury, Vice President, Clinical Trial Management, joined Syneos Health in February 2019 and is responsible for global clinical trial management and monitoring strategy. Prior to leading the global CTMs at Syneos, Nicole led the Global Central Monitoring team and risk -based... Read More →
MW

Madeleine Whitehead

RBQM CoE - Head, Roche, United Kingdom
Madeleine Whitehead is the Head of Strategic Leads in the RBQM Centre of Excellence at Roche Pharmaceuticals. During her nearly 20 year career in the industry, she has worked in both pharma and CROs as a process and Good Clinical Practice (GCP) specialist. With a robust background... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   02: ClinTrials-Ops, Session

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