返回 Agenda
Implementing Quality by Design for Clinical Trials: New Tools, Case Studies, and Multi-Stakeholder Discussion
Session Chair(s)
Ann Meeker-O'Connell, MS
Executive Director, Monitoring Excellence Head
Novartis, 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
GlaxoSmithKline, United States
Vice President, R&D Quality and Risk Management
Panelist
Fergus Sweeney, PHD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force