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Session 1: FDA Data Standards and Regulatory Compliance Update
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Advisor, Office of Regulatory Operations, CBER
FDA, United States
Session 1: FDA Data Standards and Regulatory Compliance Update
Speaker(s)
Data Standards
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
Compliance- CBER
Bhanu Kannan, MSc
FDA, United States
Consumer Safety Officer, Office of Compliance and Biologics Quality, CBER
Compliance- CDER
Jean M. Mulinde, MD
FDA, United States
Associate Director, Division of Clinical Compliance Evaluation, OSI