This is the repository of the Regulatory R Package Repository Working Group of the R Validation Hub.
Our website: https://pharmar.github.io/regulatory-r-repo-wg
Using R in submissions to healthcare regulators is challenging since the quality of any packages used must be ensured and evidence of ensuring this quality must be made available on request. This working group strives to identify and prototype at least one technical framework that can support a transparent, open, dynamic, cross-industry approach of establishing and maintaining a 'repository' of R packages with accompanying evidence of their quality and the assessment criteria, that can be used to simplify necessary in-house validation processes as much as possible. Such a cross-industry 'repository' could help with burden-sharing of validation efforts, improve quality via transparent, open peer review, and de-risk the use of public R packages for regulatory submissions. We seek a pragmatic solution, ideally endorse by key regulators. Even though we strive to keep the approach as open as possible, the initial focus lies on the pharmaceutical industriy and their regulatory environment.