diff --git a/_r_val_hub_workstream_updates.qmd b/_r_val_hub_workstream_updates.qmd index ccb009e..ade9658 100644 --- a/_r_val_hub_workstream_updates.qmd +++ b/_r_val_hub_workstream_updates.qmd @@ -1,18 +1,20 @@ ## πŸ— Key Policy Updates! -- R Submissions Working group Pioneering use of Containers for delivering - study analysis with positive health authority feedback.[^pharmasug] +### Reminder: -
- - -:::: {.fragment} -### Reminder: News within the last year - - The FDA appears to accept `.R` files through their eSUB portal[^esub]. - The FDA has released a draft of a new _Computer Software Assurance[^csa]_ guideline that seems to be increasingly the basis for their evaluation of R. + +:::: {.fragment} + +- R Submissions Working Group is working on Pilot 4: pioneering use of containers for delivering study analysis + - containerizing shiny app from Pilot 2 + - seeking positive health authority feedback [^pharmasug] + - [meeting minutes](https://rconsortium.github.io/submissions-wg/minutes.html) for updates + + :::: [^pharmasug]: [PharmaSUG 2024 #SS-376](https://www.pharmasug.org/us/2024/papers.html#SS-376) @@ -32,6 +34,8 @@ ## πŸ“ž Community Meetings +
+ ### Past meetups πŸ“† - Jun 27, 2023 - *Learnings & Reflections from Case Studies* @@ -40,18 +44,6 @@ - Feb 03, 2024 - *Unraveling the Term β€œValidation”* - May 21, 2024 - *Tackling Hurdles: Embracing Open-Source Packages in Projects* -
- -:::: {.columns} -::: {.column width="60%"} -### How do I sign up? -- βœ‰ Join our [mailing list](https://lists.r-consortium.org/g/RConsortium-Validation-Hub)! (pharmaR.org > Contract Us) -- Follow the [R Consortium's Linkedin](https://www.linkedin.com/company/r-consortium/posts/) -::: -::: {.column width="40%"} -![](resources/linkedIn-logo.png){height="200"} -::: -:::: ## πŸ“ž Next Community Meeting @@ -84,6 +76,22 @@ > In this talk, we showcase the risk assessments over time, the causes of any risk class changes, and their impact on various teams within our organizations as a result. +## πŸ“ž Community Meetings + +
+ +:::: {.columns} +::: {.column width="60%"} +### How do I sign up? +- Follow the [R Consortium's Linkedin](https://www.linkedin.com/company/r-consortium/posts/) +- βœ‰ Join our [mailing list](https://lists.r-consortium.org/g/RConsortium-Validation-Hub)! (pharmaR.org > Contact Us) +::: +::: {.column width="40%"} +![](resources/linkedIn-logo.png){height="160"} +::: +:::: + +![](resources/contact_us.png){style="border-color:black; border-style:solid; border-width:0.25em;"} ## 🚧 Website: `pharmaR.org` THEN @@ -102,7 +110,36 @@ ## πŸ†• Gathering GxP Package Lists +
+ +- **What?** + - Pkg name, version, assessment date, risk decision + +:::: {.fragment} +- **Why?** + - R Val Hub will analyze & report observed trends & consensus in aggregate + - Regulatory Repo WG to help identify which thresholds for certain quality benchmarks + +:::: + +:::: {.fragment} +- **How?** + - Will publish a form on `pharmaR.org` to Sign Up + - Can be 100% anonymous, or consider open-source + - 6 pharma Orgs verbally committed, 2 delivered already + + +:::: + + +## πŸ†• Open-sourced Package List + +::: {style="margin-left:1em; padding-top:1em"} +### πŸ”— [insightsengineering.github.io/rvalidationhub-packages/](https://insightsengineering.github.io/rvalidationhub-packages/) +::: + +![](resources/pkg-lists-roche.png){style="margin-left:3em; padding-top:1em;"} diff --git a/index.qmd b/index.qmd index e2beeaf..f0a7c9a 100644 --- a/index.qmd +++ b/index.qmd @@ -25,10 +25,9 @@ Keep your hand raised if... # πŸ—“οΈ Agenda -- Key Policy updates [2min]{.dim} -- Communications Workstream [5min]{.dim} -- `{riskassessment}` App Workstream [5min]{.dim} -- `{riskmetric}` workstream [10min]{.dim} +- Communications Workstream [6min]{.dim} +- `{riskassessment}` App Workstream [7min]{.dim} +- `{riskmetric}` workstream [7min]{.dim} _Watch for big changes coming_ - Repositories Workstream [25min]{.dim} - **Room Discussion** [10 - 15min]{.dim} diff --git a/resources/contact_us.png b/resources/contact_us.png new file mode 100644 index 0000000..e74667d Binary files /dev/null and b/resources/contact_us.png differ diff --git a/resources/pkg-lists-roche.png b/resources/pkg-lists-roche.png new file mode 100644 index 0000000..8b92cbf Binary files /dev/null and b/resources/pkg-lists-roche.png differ