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DIA 2021 Global Annual Meeting

Patient Engagement and Quality by Design: Integrating the Patient Perspective in Clinical Trial Design

Session Chair(s)

Jaye Bea Smalley, MPA

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)

Karlin Schroeder, MA

Panelist

Karlin Schroeder, MA

  • Associate Vice President, Community Engagement
  • Parkinson's Foundation, United States
Kerstin Koenig, PhD, MSc

Panelist

Kerstin Koenig, PhD, MSc

  • Vice President, Research and Development Quality
  • Bristol-Myers Squibb Company, United States
Hamid Moradi, MD

Panelist

Hamid Moradi, MD

  • Associate Director of Nephrology Fellowship Program, Medicine
  • University of California, Irvine, United States