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Wednesday, June 29 • 2:12pm - 2:30pm
Using R in a regulatory environment: FDA experiences.

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The Food and Drug Administration (FDA) regulates products which account for approximately one fourth of consumer spending in the United States of America, and has global impact, particularly for medical products. This talk will discuss the Statistical Software Clarifying Statement (http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm445917.htm), which corrects the misconception that FDA requires the use of proprietary software for FDA submissions. Next, we will describe several use cases for R at FDA, including review work, research, and collaborations with industry, academe and other government agencies. We describe advantages, challenges and opportunities of using R in a regulatory setting. Finally, we close with a brief demonstration of a Shiny openFDA application for the FDA Adverse Event Reporting System (FAERS) available at https://openfda.shinyapps.io/LRTest/.

Moderators
avatar for Rasmus Arnling Bååth

Rasmus Arnling Bååth

Lund University

Speakers
PH

Paul H Schuette

Mathematical Statistician, FDA
Regulatory Science, FDA


Wednesday June 29, 2016 2:12pm - 2:30pm
McCaw Hall 326 Galvez Street Stanford, CA 94305-6105

Attendees (118)