If you develop clinical trial programs and studies, or support them, this meeting may be of interest. Attendance can be in person or virtually. Details from the announcement:
On January 31, 2024, from 9am-4:30pm EST, the U.S. Food and Drug Administration, in partnership with the Duke-Margolis Center for Health Policy, will hold a hybrid public meeting entitled "Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches."
This meeting is an opportunity to facilitate a discussion among the clinical trials community and interested parties about challenges and successes of integrating QbD and RBM into the design and conduct of clinical studies. The objectives of this meeting are to:
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- Encourage the incorporation of QbD principles into the design and conduct of clinical studies, including the development of study protocols and workflow processes
- Identify barriers to QbD and RBM implementation by sponsors, clinical research organizations, and clinical trial sites
- Inform best practices for incorporating QbD and RBM approaches into the design and conduct of clinical studies
Participants may register to attend this hybrid meeting either virtually or in-person by visiting the Duke-Margolis website.
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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