#44: Quality by Design: From Theory to PracticeDay & Time:
June 15, 9:00AM - 5:00PM (Pacific Standard Time)Room Number:
Annemarie Forrest, MPH, MS, RN
Clincial Trials Transformation Initiative, United States
Jean Mulinde, MD
Acting Senior Advisor, Division of GCP Compliance, OSI, CDER
FDA, United States
Ann Meeker-O'Connell, MS
Senior Director, QA Clinical Strategy Team Lead
Janssen Pharmaceuticals, Inc., United States
John H. Alexander, MD
Director, Cardiovascular Research; Vice Chief, Clinical Research, Cardiology
Duke Clinical Research Institute, United StatesDescription:Maximize your learning while attending the DIA 2014 50th Annual Meeting! Receive $100 off of your DIA 2014 meeting registration by registering for two half-day tutorials or one full-day tutorial. Purchases must be made at the same time in order to receive the discount.
Quality by Design (QbD) emphasizes building quality into the process from the beginning. Applied to clinical trials, this approach prospectively defines factors critical to trial quality and identifies risks critical to those factors. This tutorial will provide an introduction to the clinical trials transformation initiative, and an overview of QbD and risk-based monitoring concepts. Working in groups, participants will apply the QbD principles to a hypothetical protocol outline, taking into account the concerns of key stakeholders.
|#44: Quality by Design From Theory to Practice ||CME|
At the conclusion of this tutorial, participants should be able to:
• Describe QbD for clinical trials from general principles, real-world examples, and hypothetical case studies;
• Identify perceived barriers and potential solutions to the adoption of QbD;
• Identify opportunities for dissemination of these principles and practices to a broad array of stakeholders in your organization.
This tutorial is designed for professionals involved in clinical safety and pharmacovigilance.