Risk-assessment of R packages in a Biopharmaceutical Regulatory Setting.

Oregon Convention Center 

This contribution reflects on framework and tools by the R Validation Hub for risk-based assessment of R packages within validated infrastructure.
The R Validation Hub is a cross-industry initiative, led by approximately 10 organizations with frequent involvement from health authorities. The R validation Hub is funded by the R Consortium and has the mission to support the adoption of R within regulated industries, with an emphasis on biopharmaceuticals.
We will discuss the framework for the risk-based assessment of R packages, that has been utilized by key pharma companies across the industry. We will also showcase the {riskmetric} R package, that evaluates the risk of an R package using a specified set of metrics and validation criteria, and the {riskassessment} app, that augments the utility of the {riskmetric} package with a Shiny app front end. Lastly, we will outline a prototype of a technical framework for a 'repository' of R packages with accompanying evidence of their quality and the assessment criteria.

R Package

Risk assessment

Open-source software

Regulated environment

validation 

Biopharmaceutical Section