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Session 7A: Business Track - Intelligence from FDA Performance Metrics
Session Chair(s)
Shanthi Sethuraman, PhD
Director, Regulatory Center of Excellence, Global Regulatory Affairs-US
Eli Lilly and Company, United States
FDA publishes various reports and information in their website. This information, when mined appropriately can provide great insight on multiple fronts such division performance, opportunities for the various expedited pathways, postmarketing requirements/commitments, postmarketing supplements and more. This session will provide examples of analyses performed, information derived from the analyses and areas of opportunities to utilize this information to enable registration strategies.
Speaker(s)
Presentation 1
Michael Hay
Sagient Research Systems, United States
Executive Vice President, Sagient Product Director
Intelligence from FDA Performance Metrics
Marija Popovic, PhD
Eli Lilly & Co., United States
Regulatory Center of Excellence
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