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Activity Number: 282 - Tools to Enable the Use of R by the Biopharmaceutical Industry in a Regulatory Setting
Type: Topic-Contributed
Date/Time: Wednesday, August 11, 2021 : 1:30 PM to 3:20 PM
Sponsor: Biopharmaceutical Section
Abstract #317411
Title: Paving the Way for Regulatory Submissions Using R: the Risk Assessment Shiny Application
Author(s): Marly Gotti*
Companies: Biogen
Keywords: risk assessment; riskmetric; shiny; R; metric; validation

In recent years, R has gained significant popularity as a statistical software in the academia mainly because it is free, open source, and vastly used in academic research. This popularity has reached the health sector and other regulated industries. As a consequence, an avalanche of concerns has been raised by statisticians, statistical programmers, quality assurance teams and others within the pharmaceutical industry about the use of R and selected R packages as primary tools for statistical analysis for regulatory submission work. To address such concerns, the R Consortium set in motion the R Validation Hub, a collaboration to support the adoption of R within a bio-pharmaceutical regulatory setting. In this paper, we will introduce the Risk Assessment Shiny Application, one of the tools currently in development by the R Validation Hub to aid in the validation of R packages in regulated environments.

Authors who are presenting talks have a * after their name.

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