Juliane Manitz & Coline Zeballos - Updates from the R Validation Hub: Towards a Pharma Repository

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  • เผยแพร่เมื่อ 12 พ.ย. 2024
  • Updates from the R Validation Hub: Towards a Pharma Repository - Juliane Manitz & Coline Zeballos
    Slides available at pharmar.github...
    Abstract: 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.
    Speaker Bios:
    My name is Juliane Manitz and I am a statistician currently work in the field of immuno-oncology at EMD Serono, USA. My academic research focused on statistical analysis of network data as well as interdisciplinary statistical consulting.
    Coline Zeballos uses her mix of business and technical experience to lead experts in delivering value. In her current position as R Strategy Lead in the Pharmaceutical division of F. Hoffmann-La Roche, Coline drives the IT strategy to support the use of open source programming languages like R and Python. Her actual focus is on enabling R package validation. Coline is passionate about discovering the world through different cultures. She has lived in Switzerland, France, USA and Bolivia and speaks French, English and Spanish. Coline recently discovered a new reason to travel when starting kitesurfing.
    Presented at the 2023 R/Pharma Conference (October 25, 2023)

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