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Evolving Data Standards and Regulations
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
This session will describe the current state and evolution of data standards.
Learning Objective : Discuss the status of required study data standards, as well as other data standards initiatives; Summarize FDA's efforts to develop, test, and support therapeutic area data standards; Describe FDA's participation in and status of international data standards initiatives.
Speaker(s)
Impact of the Binding Guidance for Standardized Study Data Internally at the FDA
Vaishali Popat, MD, MPH
FDA, United States
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER
CDASH v2.0: Whats New and What Does it Mean for Me?
Dawn Kaminski
eClinical Solutions, United States
Senior Director, Data Strategies, eClinical Solutions
CDISC Standards for Regulatory Submissions
Lauren Becnel
CDISC, United States
Vice President, Strategy and Innovation
Metadata Driven Data Operations: What is it and How Can it Transform Traditional Clinical Data Management/Analysis/Reporting
Michael Goedde
PAREXEL, United States
Vice President, Clinical Data Management and Database Programming
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