Quality by Design (QbD) emphasizes building quality into a process from the beginning. While a broad cross-section of key stakeholders in the clinical trials enterprise agree that the widespread adoption of an enlightened QbD approach to trial planning, conduct, and oversight is needed to ensure trial quality and efficiency, a lack of real-world examples of this process leave many wondering how to move from theory to practice.

To help answer these questions, two members of CTTI’s QbD Project will be presenting at the 24th Annual Partnerships in Clinical Trials Meeting in Boston, MA on April 24, 2015:

Session Title: Clinical Quality by Design – Principles to Practice

Speakers:

• Ann Meeker-O’Connell, Head, Risk Management and External Engagement, BioResearch Quality and Compliance, Johnson & Johnson Quality and Compliance
• Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer

Agenda:

• Develop understanding of Quality by Design (QbD) principles for clinical trials
• Identify perceived barriers and potential solutions to the adoption of Quality by Design
• Review opportunities for dissemination of these principles and practices to a broad array of stakeholders

We look forward to connecting with our colleagues at #PCTUS.

If you are interested in hearing more stories of translating QbD principles into practice, please join us during a one-hour CTTI-hosted webinar on April 15.