Thursday, May 26, 2022, 1:30 PM - 2:30 PM
Implementing and leading an effective quality culture that meets requirements established by regulations, directives, and standards set within ICH E8(R1) and ICH E6(R2) is an industry challenge. A proactive, risk-preventative quality culture must be pervasive across a complex, regulated, global clinical trial ecosystem of multiple partner organizations (e.g., pharma/biotech, CROs, technology/device providers, labs, investigative sites, ethics committees, regulators, etc.). Creating an integrated quality culture inclusive of processes, systems, and people across stakeholder groups is vital to ensure critical thinking and open dialogue that achieve QbD principles.
This panel of industry leaders will share their challenges and successes in effecting such integrated, sustainable quality cultures that overcome change management barriers from historical, reactive, siloed cultures across the stakeholder groups. They will share how systems, processes and proactive, quality-focused human behavior can work in harmony to ensure the protection of the rights, safety, and wellbeing of study participants, and the generation of reliable and meaningful results. The audience will have opportunities to engage with the panel members.
