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Clinical Trials Transformative Initiative (CTTI) Approach to Quality-by-Design (QbD)

1.25 credits


Full course description

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.


The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the FDA in 2007, resulted from a growing concern over the poor quality and inefficiency in clinical research as well as the increasing numbers of trials conducted outside of the United States where standards and practices greatly differ. The goal of the CTTI Quality by Design (QbD) project was to better understand the range of current practices, assess alternative approaches, understand barriers to change, and propose recommendations for improvement.The course will discuss the background, approach, and concepts from CTTI’s QbD Project, including “The Principles Document” and a real-world example case study.


  1. What is the Clinical Trials Transformation Initiative?
  2. Overview of the QbD Project
  3. CTTI’s Approach, Activities, & Recommendations
    • Creating a Culture to:
      • Value and rewards critical thinking
      • Extend beyond sole reliance on tools and checklist
    • Focus effort on activities essential to credibility on study outcomes
    • Involve stakeholders
    • Prospectively identify and periodically review ‘critical to quality factors’
  4. Principles Document: Key Concepts
    • Critical Quality Factors: Protocol Design, Feasibility, Patient Safety, Study Conduct, Study Reporting, & Third Party Engagement
  5. Application of QbD in Trial Life Cycle
    • Real World Example: Study Overview, Potential critical to quality identification, & Potential mitigation strategies
  6. Key Challenge: Reported barriers to Implementation
  7. ICH E8: Incorporation of QbD concepts
  8. CTTI QbD Toolkit: Additional Resources and Information


Eunjoo Pacifici, PharmD, PhD, is Chair and Associate Professor of Regulatory and Quality Sciences and Associate Director of International Center for Regulatory Science. Dr. Pacifici received her BS in Biochemistry from UCLA followed by PharmD and PhD in Toxicology from University of Southern California. She conducted her graduate research in the laboratory of Dr. Alex Sevanian in the Institute for Toxicology at USC where she studied the mechanism of oxidative damage and repair in endothelial cell membrane. Before returning to USC as faculty, Dr. Pacifici worked at Amgen and gained experience in conducting clinical research with special focus on Asia Pacific and Latin America regions. She initially worked in the clinical development group managing U.S. investigational sites and central laboratories; and then went on to work in the Asia Pacific/ Latin America group interfacing with local clinical and regulatory staff in Japan, People’s Republic of China, Taiwan, and Mexico. She represented regional clinical and regulatory views on therapeutic product development teams and led satellite task forces to align local efforts with U.S. activities. Her additional professional experiences include community pharmacy practice in various settings and clinical pharmacy practice at the Hospital of the Good Samaritan in Los Angeles. Her current focus is on developing the next generation of regulatory scientists and pharmacy professionals with the knowledge, tools, and skills to expedite the development of innovative, safe, and effective biomedical products.


This program is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with 3+ years of experience seeking to further develop clinical research conduct skills and principles.Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor/ CRO challenges.

Learner Level: Intermediate/ Advanced

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.Attendees to this CNE activity will be awarded 1.25 Continuing Nursing Education contact hours from ENPDC.

Need Help with Registration? Please contact us at or 404-727-9208.

Program Information: This is the second course in a five (5) session program. To complete the entire program and earn a badge CLICK HERE.

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