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R/Adoption Series: Learnings and Reflection from R Validation Hub Case Studies
Description
The R Validation Hub will review the implementation of risk-based approaches to assess R package accuracy within a validated infrastructure and present our learnings from applied case studies. The discussion reflects the thinking of the R Validation Hub working group, which is a cross-industry initiative funded by the R Consortium. Our mission is to enable the use of R by the bio-pharmaceutical industry in a regulatory setting, where the output may be used in submissions to regulatory agencies.
Time
Mar 30, 2023 08:00 AM in
Pacific Time (US and Canada)
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Hi there, You are invited to a Zoom webinar. When: Mar 30, 2023 08:00 AM Pacific Time (US and Canada) Topic: R/Adoption Series: Learnings and Reflection from R Validation Hub Case Studies Register in advance for this webinar: https://zoom.us/webinar/register/WN_Yu0Vu_iFTL21DSXle-JT_w After registering, you will receive a confirmation email containing information about joining the webinar. ---------- Webinar Speakers Juliane Manitz (Main Speaker | Senior Expert Biostatistician @EMD Serono, MA USA) Juliane Manitz is a statistician in the pharmaceutical industry who currently works in the field of immuno-oncology at EMD Serono, MA USA. In this role, she works on statistical methodology, innovation, and technology. She has contributed to various R packages and is a member of the R validation Hub executive committee working on software validation for usage in pharmaceutical trials. Doug Kelkhoff (Breakout Room Lead ) Doug Kelkhoff has been supporting the adoption of R in the pharmaceutical space for the past 6 years. During his time at Roche, he has pushed the adoption of R through pilot clinical trials, showcasing the benefits of using R by crafting internal tools and building services that embed the R Validation Hub’s guidance as part of our software development lifecycle. He is passionate about making the use of open source tools in a regulated setting a viable path not just for large pharmaceutical companies, but for lean startups and the public sector by addressing challenges through open initiatives. Uday Preetham Palukuru (Breakout Room Lead ) Uday Preetham Palukuru is a Standards lead at Merck &Co., providing leadership to develop and maintain global standards for ADaM implementation, R package development, Open Source package qualification, Computing Platform enhancements and compliance management tools. He has contributed to various internal and external R packages and is a member of the R Validation Hub Executive committee. He actively promotes the use of open source software in clinical trial data analysis via forums and paper publications. He has a PhD in Bioengineering from Temple University.
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