- 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
Eunjoo Pacifici, PharmD, PhD
Director, Regulatory Knowledge and Support