The Association of Clinical Research Professionals
FEAR: Face Everything and Rise (in Clinical Research)
In an evolving clinical research landscape, quality and innovation must go hand in hand.
In this dynamic session, David Burrow, PharmD, JD, explored foundational principles of Quality by Design (QbD), including Critical to Quality (CTQ) factors and Risk-Based Quality Management Systems (RBQM). Participants gained strategic insights into how to enhance trial quality while reducing regulatory uncertainty through forward-thinking approaches and practical tools.
Beyond systems and frameworks, the session also examined the human side of quality, offering actionable strategies to overcome fear, build confidence, and foster a culture of resilience. Whether attendees were looking to elevate team performance or strengthen their mindset, the session provided both the technical and emotional intelligence tools needed to thrive in today’s research environment.
Upon completion of this continuing education program, participants should be able to:
Discuss key themes of QbD, CTQ factors, and RBQM systems.
Provide strategies to advance innovation and enhance quality while minimizing regulatory uncertainty.
Offer actionable approaches to mitigate fear, both individually and across organizations.
Speaker:
David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration