End to End RBQM Education
Project Description |
This initiative will provide Community Forums to present and discuss RBQM-related topics, supporting broader industry education. Planned topics include CtQs, RBQM and technology, risk assessments, central monitoring analytics, QTLs, AI/ML, and change management. There remains a significant need for foundational RBQM education across the industry, including its core components and effective implementation. In addition, limited regulatory feedback, particularly from the FDA, has contributed to uncertainty, highlighting an opportunity for collaborative educational efforts. Misconceptions and lack of understanding have delayed adoption within many organisations. Although RBQM approaches can improve data quality and operational efficiency across functions such as data management, medical monitoring and clinical operations, these benefits are not fully realised due to hesitancy in applying risk-based methods. These forums aim to address knowledge gaps, encourage engagement, and support more consistent adoption of RBQM practices. |
Project Leads | |
|---|---|
Ann Fleenor, Astellas | |
Jennifer Krohn, Gilead | |
Shawntel Swannack, Johnson & Johnson | |
Alex Pearce, PHUSE Project Coordinator |
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