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Regulatory Submissions, Information, and Document Management Forum


Session 1: FDA Data Standards and Regulatory Compliance Update

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

  • Senior Informatics Advisor, Office of the Director, CBER
  • FDA, United States
Session 1: FDA Data Standards and Regulatory Compliance Update

Speaker(s)

Mary Ann  Slack

Data Standards

Mary Ann Slack

  • Director, Office of Strategic Programs, CDER
  • FDA, United States
Bhanu  Kannan, MSc

Compliance- CBER

Bhanu Kannan, MSc

  • Consumer Safety Officer, Office of Compliance and Biologics Quality, CBER
  • FDA, United States
Jean M. Mulinde, MD

Compliance- CDER

Jean M. Mulinde, MD

  • Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI
  • FDA, United States