Senior Informatics Advisor, Office of the Director, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions...
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Microbiologist/Primary Reviewer, OVRR/DVRPA, CBER, FDA, United States
Dr. Baldwin is a Primary Reviewer in the Office of Vaccines Research and Review (OVRR) at the FDA. In addition to her review activities, Dr. Baldwin has become the leading expert in OVRR on the use of clinical study standardized data. Dr. Baldwin’s involvement with CDISC began in...
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Project Management Officer, OSP, CDER, FDA, United States
Mr. Chen is a project management Officer at Office of Strategic Programs, CDER, US Food and Drug Administration, where he is responsible for the development and implementation of electronic data standards for CDER regulatory review. As an FDA delegate to ICH E2B Expert Working Group...
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Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining...
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