R/Adoption Series: R and Shiny in Regulatory Submissions

In this talk, the FDA and industry speakers will share their unique experiences with R-based and shiny-based submissions.

- Opening Remarks by Ning Leng, People and Product Lead in Product Development Data Sciences at Roche.
- Presentation on Open Source Software for Regulatory Submissions by Paul Scheutte, FDA.
- Dive into R Consortium R Submission Pilot 2 with Eric Nantz from Eli Lilly. Discover how an R-based submission with a shiny component unfolded.
- Reviewing Experience of R-based Submissions with Hye Soo Cho, FDA. Understand the nuances and challenges faced during the review process.
- Interactive Panel Discussion moderated by Ning Leng. Join Paul Schuette, Hye Soo Cho, and Eric Nantz as they delve deep into the R adoption journey and discuss practical challenges and solutions.

#Rstats #Opensource #rprogramming

Main Sections

00:00 Introduction
05:50 Paul's Presentation: Open Source Software for Regulatory Submissions
23:03 Eric's Presentation: R Consortium R Submission Pilot 2
48:19 Hye Soo's Presentation: Reviewing Experience of R-based Submissions
01:05:53 Q&A
01:14:35 FDA answering about Validation

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