Quality by Design: Leading Practices, Systems and Behaviors

Wednesday, May 25, 2022, 12:45 PM - 2:00 PM

Building quality into clinical trial programs up front during protocol design and maintaining quality throughout the conduct of each trial has become a focus of regulators and clinical researchers. ICH E8(R1) focuses on this by stating, “The quality by design approach to clinical research (Section 3.1) involves focusing on critical to quality factors to ensure the protection of the rights, safety, and wellbeing of study participants, the generation of reliable and meaningful results, and the management of risks to those factors using a risk-proportionate approach (Section 3.2).” In addition, ICH E6(R2), the anticipated ICH E6(R3), and recently established regulatory regulations and directives have adopted these QbD principles.

This breakout session, facilitated by Steve Whittaker, WCG Avoca Senior Consultant, and Jonathan Rowe, ZS Principal and Head of R&D Quality and Operations Risk Management, will engage participants in an open, interactive dialogue regarding leading practices, systems, and behaviors that enable effective implementation of these QbD principles when conducting clinical trials while taking into consideration that planning and execution must occur across numerous stakeholder groups (e.g., sponsors, CROs, technology/device providers, labs, investigative sites, ethics committees, regulators, etc.).