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.
This webinar provides a comprehensive guide to developing, implementing, and maintaining effective SOPs tailored to the unique needs of research sites. Attendees learned practical strategies to streamline processes, enhance regulatory compliance, and foster team collaboration.
This interactive webinar reflected on the need for culturally competent research and advocacy, the complexity of the Latinx identity, and the need to reflect on how we relate to the Latine identity.
In the final session of the series, focus shifted to provisions designed to protect all parties from potential liabilities while fostering a safer trial environment. Topics included indemnification and letters of indemnification, subject injury, and insurance.
In part two of the series, attendees had the opportunity to hear from clinical trial attorneys as they shared insights on critical regulatory issues that can impact the trial’s legality. This session covered Medicare billing, Anti-Kickback Statute and the Personal Services Safe Harbor, and privacy.