The use of R in submissions to healthcare regulators presents challenges as the quality of packages must be ensured, and evidence of this quality must be readily available. The Regulatory R Package Repository Working Group aims to tackle these issues by identifying and prototyping a technical framework that supports a transparent, open, dynamic, and cross-industry approach to creating and maintaining a repository of R packages, complete with evidence of their quality and assessment criteria. This initiative aims to streamline in-house validation processes, facilitate burden-sharing of validation efforts, improve package quality through transparent, open peer review, and minimize risks associated with using public R packages for analyses submitted to regulatory bodies. Over the past few months, the group has recruited key representatives, including validation managers and regulatory authorities, conducted stakeholder interviews, and explored product concepts. This talk will present the key findings from the stakeholder interviews, discuss the product concepts generated thus far, and outline the future steps for the Regulatory R Package Repository Working Group.
Juliane Manitz | Coline Zeballos
EMD Serono | Roche
Updates from the R Validation Hub: Towards a Pharma Repository
The use of R in submissions to healthcare regulators presents challenges as the quality of packages must be ensured, and evidence of this quality must be readily available. The Regulatory R Package Repository Working Group aims to tackle these issues by identifying and prototyping a technical framework that supports a transparent, open, dynamic, and cross-industry approach to creating and maintaining a repository of R packages, complete with evidence of their quality and assessment criteria. This initiative aims to streamline in-house validation processes, facilitate burden-sharing of validation efforts, improve package quality through transparent, open peer review, and minimize risks associated with using public R packages for analyses submitted to regulatory bodies. Over the past few months, the group has recruited key representatives, including validation managers and regulatory authorities, conducted stakeholder interviews, and explored product concepts. This talk will present the key findings from the stakeholder interviews, discuss the product concepts generated thus far, and outline the future steps for the Regulatory R Package Repository Working Group.