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 60-minute webinar is designed to help clinical research, regulatory affairs, and GCP quality professionals decode the complexities of the updated guidance. The speaker breaks down the key shifts, themes, and differences between R2 and R3, provides real-world examples to simplify the changes, and introduces a framework to help identify gaps and prioritize the next steps for compliance.
This exciting webinar was led by an inspiring patient advocate and voice for the community as she discussed how to build awareness, strategies, and the idea of technical empathy and how we all can benefit.
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.