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Clinical Quality by Design: From Theory to Practice
Session Chair(s)
Ann Meeker-O'Connell, MS
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
FDA, United States
QbD emphasizes building quality into a process from the beginning and has been successfully applied in the manufacturing arena. Applied in clinical development, QbD prospectively examines a trial's objectives and identifies the factors that are critical to meeting these objectives. Understanding these “critical to quality” aspects is essential to subsequently identifying and managing important and likely risks to trial quality. To support organizations seeking to implement QbD, a Clinical Trials Transformation Initiative (CTTI) project team is currently developing a portfolio of learning and operational tools. In addition, we will review these tools and highlight effective strategies that may aid in adoption of a QbD approach. This session will also discuss how pragmatic protocol design drawing on data standards and simulations may augment trial design and examine ways of leveraging insights from health care providers and payers to inform and improve protocol design.
Learning Objective : Describe strategies for implementing clinical quality by design (QbD) to build quality into the design and operations of clinical trials; Review tools and case studies from by the CTTI QbD project team to suport implementation of clinical QbD; Examine ways of leveraging insights from health care providers and payers to inform and improve protocol design.
Speaker(s)
From Principles to Practice: An Industry Perspective
Coleen Glessner, MBA
Alexion Pharmaceuticals, United States
Senior Vice President, Chief Quality Officer
Towards More Effective Protocols and Safer Trials Starting With Standards and Simulating Designs
James Streeter
Oracle Health Sciences, United States
Global Vice President, Life Sciences Product Strategy
FDA Point of View
Jean M. Mulinde, MD
FDA, United States
Associate Director, Division of Clinical Compliance Evaluation, OSI
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