Status Update May 2022

By Juliane Manitz on May 20, 2022

It’s time to bring another update to you on the current status of the R validation hub: The riskmetric R package has been stable on CRAN. Recent work has focused on structuring “cohort metrics” – metrics that are conditioned on the package library or execution environment available to R. In R, package behaviors are often dependent on the rest of the R installation, and this new feature will help to make metrics more inspectible and reproducible, as well as allowing us to ask new questions like, “What would be the effect of installing a new package into an R environment?

Risk Assessment App Update

By Joseph Rickert on February 3, 2022

This is a re-post. The original post from the R Consortium can be found here Recent update by Marly Gotti on the Risk Assessment Shiny App. Marly is an executive committee member of the R Validation Hub where she advocates for the use of R within a biopharmaceutical regulatory setting, and Senior Data Scientist at Biogen. The Risk Assessment App is an interactive web application serving as a front end application for the riskmetric R package.

Some Considerations on Trusted Resources

By Juliane Manitz, Yilong Zhang, and Andy Nicholls on January 7, 2022

There is a large variety of contributed R packages, which can be overwhelming when performing their accuracy assessment. These packages can be developed by anyone and may differ in accuracy. The white paper mentions the possibility to define “trusted resources” to simplify the assessment for some of the R packages. The idea follows vendor assessments / audits to explore the internal validation practices of the vendor for proprietary software. For open-source software such audits are not logistically feasible.

Status Update: R Validation Hub at R/Pharma 2021

By Juliane Manitz on October 19, 2021

Our favorite meeting of the year is approaching: R/Pharma 2021 will be held virtually November 2-4th, 2021. Also watch out for workshops the week before. Since the R validation Hub is closely associated with R/Pharma, we would like to highlight some of the presentations inspired by the R validation Hub, partner initiatives, or generally related to the topic of validation. Tuesday: November 2, 2021 11:00am “R Package Validation at Roche” by Coline Zeballos, Roche 11:20am “Statistical Analysis and Pathway to a Risk-based Assessment of R packages at Merck KGaA/EMD Serono” by Juliane Manitz, EMD Serono 1:50 PM “Panel Discussion – Validation” with representatives of the R validation Hub” Wednesday: November 3, 2021

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Status Update May 2022

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Some Considerations on Trusted Resources

Status Update: R Validation Hub at R/Pharma 2021

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