Presentations

2021

November
- R/Pharma 2021 Presentation: Performing a risk assessment of R packages using the Risk Assessment Shiny Application, Marly Gotti
October
- rOpenSci Community Call: Expanding Software Peer Review: Statistical Package Standards at rOpenSci, Juliane Manitz
September
- ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop: Contributed session “Tools to enable the use of R by the bio-pharmaceutical industry in a regulatory setting”, organizer/chair: Juliane Manitz
  - Paul Schuette: R for Regulatory Submissions: Challenges and Approaches
  - Mark Padgham: Assessment and Standardization of R Packages for Statistical Analysis by ROpenSci
  - Juliane Manitz on behalf of the R validation Hub: A Risk-based approach for assessing R package accuracy within a validated infrastructure
  - Discussion and Q&A
  - Organizer/Chair: Juliane Manitz
August
- Joint Statistical Meetings: Topic-contributed session “Tools to enable the use of R by the bio-pharmaceutical industry in a regulatory setting”, organizer/chair: Juliane Manitz
  - Paulo Bargo (Abstract #317506): A Risk-based approach for assessing R package accuracy within a validated infrastructure
  - Doug Kelkhoff (Abstract #317498): A workflow to evaluate the quality of R packages using the R package riskmetric
  - Marly Gotti (Abstract #317411): A case study: performing a risk assessment on the tidyverse package using the Risk Assessment Shiny Application
  - Mark Padgham (Abstract #317480): Packages for automated assessment and standands alignment of R packages
  - Yilong Zhang (Abstract #317189): r2rtf - a lightweight R package to produce submission-ready tables and figures in RTF format
July
- useR!: R in Regulated Industries: Assessing Risk with riskmetric, July, Doug Kelkhoff, see recording
June
- Annual Meeting of Statisticians in Pharmaceutical Industry (PSI; June 21-23, 2021): Contributed session
  - Andy Nicholls (GSK) and Paulo Bargo (Janssen R&D): A Risk-based approach for assessing R package accuracy within a validated infrastructure
  - Douglas Kelkhoff (Roche/Genentech): A workflow to evaluate the quality of a set of R packages using the R package riskmetric
  - Marly Gotti (Biogen): A case study: performing a risk assessment on the tidyverse package using the Risk Assessment Shiny Application
  - Keaven Anderson (Merck & Co): Considerations for Testing of R packages
  - Yilong Zhang (Merck & Co): r2rtf - a lightweight R package to produce submission-ready tables and figures in RTF format
April
- National Institute of Statistical Sciences, April, Andy Nicholls
January
- rstudio::global Risk Assessment Tools: R Validation Hub Initiatives, January, Marly Gotti