Module 12 Presentations

26/01/2024

US Regulatory Requirements

Nancy Pire-Smerkanich, MS, DRSc Assistant Professor, Department of Regulatory and Quality Sciences, University of Southern California School of Pharmacy, USA 1Feb2024

The Organisation for Professionals in Regulatory Affairs

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AGENDA TOPICS

 US Data Standards and Resources  CDISC  SDTM and ADaM  SEND  Reviewer’s Guides  Data Traceability and Accountability  eLabeling - SPL  US FDA KASA System

The Organisation for Professionals in Regulatory Affairs

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