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Patient Engagement and Quality by Design: Integrating the Patient Perspective in Clinical Trial Design
Session Chair(s)
Jaye Bea Smalley, MPA
Head of Patient Advocacy
Immunovant, United States
Global regulatory frameworks increasingly emphasize patient input in study design. In this forum, understand how the Quality by Design approach emphasized in the modernization of ICH E8 can drive effective engagement starting early in trial planning.
Learning Objective : Discuss the role of patient engagement in a Quality by Design (QbD) approach to study planning, as highlighted in the modernization of ICH E8; Identify QbD-related decision points in trial planning, opportunities for patient input, and resources to support effective engagement; Describe the broader value proposition of an integrated approach to Quality by Design and patient engagement.
Speaker(s)
Panelist
Karlin Schroeder, MA
Parkinson's Foundation, United States
Associate Vice President, Community Engagement
Panelist
Kerstin Koenig, PHD, MSC
GlaxoSmithKline, United States
Vice President, R&D Quality and Risk Management
Panelist
Hamid Moradi, MD
University of California, Irvine, United States
Associate Director of Nephrology Fellowship Program, Medicine