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CLICK HERE for the meeting agenda.

Meeting Background The goal of this meeting is to seek solutions for challenges in study design and conduct of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) studies by applying the Quality by Design (QbD) principles.

Meeting Presentations*

• Introduction and Meeting Goals by Pamela Tenaerts

Session 1: The Challenges of HABP/VABP Trials

• Summary of Challenges Identified and Categorized by Brad Spellberg
• Operational Challenges in HABP/VABP Trial Conduct by Charles Knirsch
• Operational Challenges in HABP/VABP Trial Conduct by David Friedland

Session 2: How can QbD be used to address the challenges in HABP/VABP trials?

• Introduction to a QbD Approach to Clinical Trials by Martin Landray
• Enhancing Trial Efficiency While Promoting Quality-A Regulatory Perspective by Ann Meeker-O'Connell
• Workgroup Instructions

*The views and opinions expressed in these presentations are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.