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Interactive Safety Graphics in the Regulatory Decision-Making Process
Session Chair(s)
Greg Ball, PHD
Safety Data Scientist, ASAPprocess, United States
Different visionary options may lead to a different look and feel to clincial study reports (CSRs) and submissions:
Let’s continue the discussion on how best to collaborate on interactive safety review strategy and development.
Learning Objective : Identify the impact of interactive displays on submission content and the review process including the clinical study report (CSR) and trial data submission, use of review software, and answering information requests.
Speaker(s)
Panelist
Principal, Bethesda Pharmaceutical Consulting, LLC, United States
Panelist
Deputy Division Director, FDA, United States
Panelist
Head of Data Science and Statistics, Wildfell Software, United States
Panelist
Secretary to the Authority, Uganda National Drug Authority, Uganda
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