- Agenda
- Clinical Trials Transformative initiative - CTTI
- CTTI activities
- Origins of QbD project
- Origin of CTTI’s work on QbD
- CTTI’s approach
- Reframing quality
- CTTI QbD Recommendations
- Underlying assumptions
- Principles Document: Key concepts
- CTTI QbD: Critical quality factors
- Exploring critical to quality factors
- Example: Eligibility criteria
- Example: Blinding
- Example: Withdrawal criteria / Subject retention
- Example: Data monitoring and management
- Application of QbD in the trial life cycle
- Real world example: A case study
- What are potential critical factors to quality aspects of this trial?
- Potential mitigation strategies
- Are we there yet?
- One key challenge
- Reported barriers to implementation
- Ongoing “GCP Renovation” incorporates QbD concepts into ICH E8
- CTTI QbD toolkit
- Learn about QbD
- Introduce QbD
- Adopting QbD
- Resources on the web
Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 3: CTTI’s Approach to QbD (2020)
In this series, we will discuss the principles of quality by design.
Research & Study Design
Regulatory & Quality Sciences
Eunjoo Pacifici, PharmD, PhD
Chair and Associate Professor of Regulatory and Quality Sciences Associate Director, D. K. Kim International Center for Regulatory Science
Topics
Acknowledgement
Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy | atambe@usc.edu
