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Implementing Quality by Design for Clinical Trials: New Tools, Case Studies, and Multi-Stakeholder Discussion
Session Chair(s)
Ann Meeker-O'Connell, MS
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
FDA, United States
The modernization of ICH E8 emphasizes a Quality by Design (QbD) approach to trial design. In this forum, discover new QbD resources for sponsors and all stakeholders, and join a discussion on implementation models and best practices.
Learning Objective : Compare diverse models of QbD implementation at the trial and company/organization levels, and identify best practices; Discuss benefits and best practices for multi-stakeholder engagement in the QbD process, including patients, sites, CROs, and regulators; Explain how to apply freely-available resources for evaluating current state of QbD adoption, developing an implementation and tracking progress.
Speaker(s)
Orion-4: A Case Study of QbD Application at the Trial Level
Sabrina Comic-Savic, MD, MPH
Novartis, United States
Vice President, Quality Assurance, Clinical Project Oversight
CTTI QbD Maturity Model
Kerstin Koenig, PhD, MSc
GSK, United States
Vice President, Global Quality Assurance
Panelist
Fergus Sweeney, PhD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force
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