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Data Standards Strategy
Session Chair(s)
Steve Wilson, PhD
Senior Staff Fellow, OB, OTS, CDER
FDA, United States
Study data standards are a critical factor in improving the overall effectiveness and efficiency of the regulatory review process. This session will provide an overview of FDA’s commitment to the use of open, consensus-based data standards that will facilitate the efficient review of regulatory submissions. The discussion will include topics on the data standards strategy, data governance structure and planned guidances. In addition, the session will discussion data standards issues and tools from the reviewer’s perspective. Lastly, an industry perspective on data standards will be provided.
Learning Objective : Discuss key issues, policy and guidance related to electronic standardized study data standards; Recognize the impact of policy changes on planned requirement for standardized study data standards; Identify and discuss opportunities for FDA and industry to ensure success in the area of data standards; Identify issues related to the submission of electronic study data from the reviewer’s perspective; Discuss the industry’s perspective on standardized data standards.
Speaker(s)
FDA Perspective on Data Standards
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
CDISC Perspective on Data Standards
Bron Kisler
Nurocor, United States
Senior Vice President Customer Alliances and Partnerships
FDA's Efforts on the Health Care Side Related to Data Standards
Mitra Rocca, MSc
FDA, United States
Associate Director, Medical Informatics, Office of Translational Science, CDER
Industry Perspective on Data Standards
Michael J. Brennan, PhD
Johnson & Johnson Pharmaceutical Research & Development, LLC, United States
Director, Translational Informatics
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