SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

Optimizing Your Study Data Submissions to FDA – Files Page

July 13, 2017:

Updates to the Study Data Technical Conformance Guide
Ron Fitzmartin, PhD, MBA
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Providing Clinical Study Data to the Office of Vaccines
Brenda Baldwin, PhD and Kirk Prutzman, PhD./td>

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Perspectives from CBER’s Office of Compliance and Biologics Quality (OCBQ)
Bhanu Kannan
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Combined Q&A session for above three presentations
All Speakers
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