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List of conferences / events for 2023 and status

R/Pharma 2023

Status: Accepted 20min talk

Title: “Updates from the R Validation Hub: Toward a Pharma Repository”

Authors: Juliane Manitz and Coline Zeballos

Time: Tuesday Oct 25, 11.40-12 ET

posit::conf(2023)

Sept 17-20, Chicago

status: abstract submitted

https://posit.co/conference/

R Adoption series 2023

March 30th, 2023

Recording: https://www.r-consortium.org/r-adoption-series-learnings-and-reflection-from-r-validation-case-studies

ShinyConf 2023

Mar 15-17, virtual

status: accepted

https://shinyconf.appsilon.com/

AstraZeneca R Conference 2023

June 7th, virtual status: accepted (Lyn presenting keynote for CAMIS & R Validation Hub)


List of conferences / events for 2022 and status

rstudio::conf(2022)

July 25-28 to National Harbor, DC

To submit a talk, you’ll need to create a 60 second video Proposals due March 21.

https://www.rstudio.com/blog/save-the-date/

phUSE conferences

Andy asks colleague

R/Pharma

Nov 8-11, 2022

R/Medicine

TBA

useR!

Online, June 20-23, 2022

https://user2022.r-project.org/participate/call-for-abstracts/

Status: Abstract submitted

Title: Learnings and Reflection on the Implementation of Risk-based Package Assessment

Abstract: This contribution has the aim to reflect on the implementation of risk-based approaches to assess R package accuracy within a validated infrastructure. The discussion reflects 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. In early 2020, the R validation Hub has published a white paper which addresses concerns raised by statisticians, statistical programmers, informatics teams, executive leadership, quality assurance teams and others within the pharmaceutical industry about the use of R and selected R packages as a primary tool for statistical analysis for regulatory submission work. In the meanwhile, the R consortium has successfully submitted a fully R-based test package to FDA and various companies have implemented the concept of risk-based R package validation into their standard processes. We will present our learnings from those applied case studies. We highlight which aspects were easy to implement into practice and where difficulties occurred. We also review how new developments in the riskmetric R package and shiny app can help with the recent learnings.


List of conferences / events for 2021 and status

NISS Meetup

April 21, 2021; https://www.niss.org/events/niss-merck-meet-open-source-software-pharma

Status: 'Open access software in pharma': Accepted

Slides: https://www.niss.org/file/niss202104andynichollspdf

Recording: https://www.youtube.com/watch?v=RkNtyBOkJk8

PSI

June 21-23, 2021; https://psiweb.org/conferences/about-the-conference

Status: Session accepted

Time: June 22, 3:30pm-5pm UK (i.e. 10:30am-12:00pm EST)

Presenters / Titles (each 15mins):

  • 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

DIA

June 27-July 1, 2021, virtual https://www.diaglobal.org/en/flagship/dia-2021

Status:

  • ContentHub not submitting due to high costs
  • Andy I will present very similar initiative by TransCelerate and may slip the R Validation Hub into his talk.

useR!

July 5-9, 2021, virtual; https://user2021.r-project.org/

Status: Abstract accepted

Presenter: Doug

Title: R in Regulated Industries: Assessing Risk with {riskmetric}

JSM

August 7-12, 2021, Seattle WA/virtual; https://ww2.amstat.org/meetings/jsm/2021/

Status: Session accepted

Submission type: Contributed Session

Wed Aug 11, 1.30-3pm (EST).

Presenters / Titles (each 20mins):

  • 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 (https://mpadge.github.io/presentations/2021/JSM)
  • Yilong Zhang (Abstract #317189): r2rtf - a lightweight R package to produce submission-ready tables and figures in RTF format

R/Medicine

August 24-27, 2021; Virtual https://r-medicine.org

Status: Abstract Submitted Title: Performing Risk Assessments of R Package Accuracy using Shiny Abstract: In this presentation we introduce the Risk Assessment Shiny application and explain how it can be used to perform a risk assessment of R package accuracy within a validated infrastructure as required within a biopharmaceutical regulatory setting. The Risk Assessment Shiny Application is an interactive web application that serves as an interface to the riskmetric package. Both tools have been developed by the R validation hub, which is a cross-industry initiative funded by the R Consortium. The shiny application portraits the metrics coming from riskmetric, categorized into maintenance, community usage, and testing. The application can be used to record comments on the metrics, which are stored in an underlying database. This makes it possible to stop and start reviews at the reviewer’s convenience. Once a review is complete, a final summary comment can be provided before a final decision is made on the package. In line with the white paper, the decision is an overall risk score: low, medium, or high. The reviewer is then able to generate either an HTML or a DOCX report containing the metrics, comments, and some additional high-level information about the package.

ASA BIOP

Sept 21-23, 2021; Rockville MD; https://ww2.amstat.org/meetings/biop/2021/

Status: Session pre-selected Title: Tools to Enable the Use of R by the Biopharmaceutical Industry in a Regulatory Setting Time slot: 9/24/2021, from 2:15:00 PM-3:30:00 PM ET.

Presenters / Titles:

  • Paul Schuette: R for Regulatory Submissions: Challenges and Approaches
  • Mark Padgham
  • Discussion panel: RvalHub Representatives Juliane Manitz, Keaven Anderson, Yilong Zhang

Other Potential Conferences

  • R/Pharma

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