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DIA 2021 Global Annual Meeting
Patient Engagement and Quality by Design: Integrating the Patient Perspective in Clinical Trial Design
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.
Karlin Schroeder, MA
- Associate Vice President, Community Engagement
- Parkinson's Foundation, United States
Kerstin Koenig, PhD, MSc
- Vice President, Research and Development Quality
- Bristol Myers Squibb, United States
Hamid Moradi, MD
- Associate Director of Nephrology Fellowship Program, Medicine
- University of California, Irvine, United States