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.


  1. Agenda
  2. Clinical Trials Transformative initiative - CTTI
  3. CTTI activities
  4. Origins of QbD project
  5. Origin of CTTI’s work on QbD
  6. CTTI’s approach
  7. Reframing quality
  8. CTTI QbD Recommendations
  9. Underlying assumptions
  10. Principles Document: Key concepts
  11. CTTI QbD: Critical quality factors
  12. Exploring critical to quality factors
  13. Example: Eligibility criteria
  14. Example: Blinding
  15. Example: Withdrawal criteria / Subject retention
  16. Example: Data monitoring and management
  17. Application of QbD in the trial life cycle
  18. Real world example: A case study
  19. What are potential critical factors to quality aspects of this trial?
  20. Potential mitigation strategies
  21. Are we there yet?
  22. One key challenge
  23. Reported barriers to implementation
  24. Ongoing “GCP Renovation” incorporates QbD concepts into ICH E8
  25. CTTI QbD toolkit
  26. Learn about QbD
  27. Introduce QbD
  28. Adopting QbD
  29. Resources on the web


Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy |


Eunjoo Pacifici, PharmD, PhD
Chair and Associate Professor of Regulatory and Quality Sciences Associate Director, D. K. Kim International Center for Regulatory Science

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.