FEAR: Face Everything and Rise (in Clinical Research)
In an evolving clinical research landscape, quality and innovation must go hand in hand.
Date: July 30, 2025
Time: 12:00 – 1:00 PM ET
In this dynamic session, David Burrow, PharmD, JD, will explore foundational principles of Quality by Design (QbD), including Critical to Quality (CTQ) factors and Risk-Based Quality Management Systems (RBQM). Participants will gain strategic insights into how to enhance trial quality while reducing regulatory uncertainty through forward-thinking approaches and practical tools.
Beyond systems and frameworks, this session will also explore the human side of quality, offering actionable strategies to overcome fear, build confidence, and foster a culture of resilience. Whether you’re seeking to elevate team performance or strengthen your mindset, this session equips you with both the technical and emotional intelligence tools needed to thrive in today’s research environment.
Note: Registration is limited to 500 attendees. We encourage you to register early to guarantee your spot.
Watch a Sneak Peek into the Webinar Content:
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
David Burrow serves as the Director of the Office of Scientific Investigations (OSI), within the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). In this role, David leads efforts to shield the American public from unsafe and ineffective drug products. His leadership in the Agency’s Bioresearch Monitoring (BIMO) program includes the development and implementation of policies, surveillance activities, and compliance strategies for CDER-regulated products. Additionally, he oversees the enforcement of clinical and non-clinical drug product studies, bioequivalence studies, human subject protections, post-marketing adverse drug experience reporting requirements, risk evaluation and mitigation strategies, and post-marketing requirements. David holds a Doctor of Pharmacy from Duquesne University and a Juris Doctor from Widener University School of Law. He is licensed to practice law in the State of Maryland.
Approved for 1.0 ACRP Contact Hours