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Wednesday, June 30 • 2:00pm - 3:00pm
#338 SL: Patient Engagement and Quality by Design: Integrating the Patient Perspective in Clinical Trial Design

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-618-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Jaye Bea Smalley, MPA


Karlin Schroeder, MA

Kerstin Koenig, PhD, MSc

Hamid Moradi, MD

avatar for Jaye Bea Smalley

Jaye Bea Smalley

Head of Patient Advocacy, Immunovant, United States
Jaye Bea joined Immunovant as the Head of Patient Advocacy in 2020. Her twenty-five-year career in health care includes extensive experience in the public and private sector focused on advancing the needs and interests of patients and caregivers. Prior to joining Celgene, Jaye Bea... Read More →
avatar for Kerstin Koenig

Kerstin Koenig

Vice President, Research and Development Quality, Bristol-Myers Squibb Company, United States
Kerstin Koenig, PhD is the Head of Research & Development Quality, Bristol Myers Squibb. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance and quality management activities in the area of Product Development Quality, GLP... Read More →

Hamid Moradi

Associate Director of Nephrology Fellowship Program, Medicine, University of California, Irvine, United States
Dr. Moradi is a board certified nephrologist and a physician-scientist. He is an Associate Professor of Medicine at University of California, Irvine (UCI) and has been one of the project leads for implementation of Quality by Design (QbD) at UC Irvine Institute for Clinical and Translational... Read More →
avatar for Karlin Schroeder

Karlin Schroeder

Associate Vice President, Community Engagement, Parkinson's Foundation, United States
Karlin Schroeder, M.A., is the Associate Vice President of Community Engagement at the Parkinson’s Foundation, where she leads the Research Advocacy program. Through this program, Karlin creates and directs projects to incorporate patient expertise into research design and implementation... Read More →

Wednesday June 30, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum |   02: ClinTrials -ClinOps, Forum