Senior Informatics Advisor, Office of the Director, CBER, FDA
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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Study Data Standards Manager, Office of Director, CBER, FDA
Lisa Lin has worked as a Study Data Standards manager at FDA CBER for over a year. Currently she is responsible for all study data standards projects in CBER, including data validation, evaluation and testing of SEND standard for CBER, data analysis tool training and support. Before...
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Project Management Officer, OSP, CDER, FDA
TJ is a project management Officer at Office of Strategic Programs, CDER, FDA, where he is responsible for the development, testing, and implementation of electronic data standards for CDER regulatory review. As a FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he...
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Data Standards Program Lead, OSP, CDER, FDA
Ray Wang, MS, MBA leads the Data Standards Team within CDER’s Office of Strategic Programs. He is responsible for managing CDER’s Data Standards Program portfolio that covers a spectrum of projects that include Study Data, Product Quality Data, Postmarket Data standards development...
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Associate Director for Risk Assessment, OBE, CBER, FDA
Mark Walderhaug is an interdisciplinary scientist in FDA's Center for Biologics Evaluation and Research (CBER). He works in the Office of Biostatistics and Epidemiology where he is the Associate Office Director for Risk Assessment. He is currently working on incorporating the computational...
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