×
Back to Agenda
Evolving Data Standards and Regulations
Session Chair(s)
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, 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
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States
CDASH v2.0: Whats New and What Does it Mean for Me?
VP Business Development Operations, eClinical Solutions, United States
CDISC Standards for Regulatory Submissions
Vice President, Strategy and Innovation, CDISC, United States
Metadata Driven Data Operations: What is it and How Can it Transform Traditional Clinical Data Management/Analysis/Reporting
Vice President, Clinical Data Management and Database Programming, PAREXEL, United States
Have an account?