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
Sept 17-20, Chicago
status: abstract submitted
March 30th, 2023
Mar 15-17, virtual
status: accepted
https://shinyconf.appsilon.com/
June 7th, virtual status: accepted (Lyn presenting keynote for CAMIS & R Validation Hub)
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/
Andy asks colleague
Nov 8-11, 2022
TBA
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.
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
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):
June 27-July 1, 2021, virtual https://www.diaglobal.org/en/flagship/dia-2021
Status:
July 5-9, 2021, virtual; https://user2021.r-project.org/
Status: Abstract accepted
Presenter: Doug
Title: R in Regulated Industries: Assessing Risk with {riskmetric}
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):
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.
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: