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Add gxp pkg list request slides
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aclark02-arcus committed Aug 8, 2024
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77 changes: 57 additions & 20 deletions _r_val_hub_workstream_updates.qmd
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## 🗝 Key Policy Updates!

- R Submissions Working group Pioneering use of Containers for delivering
study analysis with positive health authority feedback.[^pharmasug]
### Reminder:

<br>


:::: {.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)
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## 📞 Community Meetings

<br>

### Past meetups 📆

- Jun 27, 2023 - *Learnings & Reflections from Case Studies*
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- Feb 03, 2024 - *Unraveling the Term “Validation”*
- May 21, 2024 - *Tackling Hurdles: Embracing Open-Source Packages in Projects*

<br>

:::: {.columns}
::: {.column width="60%"}
### How do I sign up?
- ✉ 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/)
:::
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![](resources/linkedIn-logo.png){height="200"}
:::
::::


## 📞 Next Community Meeting
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> 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.

## 📞 Community Meetings

<br>

:::: {.columns}
::: {.column width="60%"}
### How do I sign up?
- Follow the [R Consortium's Linkedin](https://www.linkedin.com/company/r-consortium/posts/)
- ✉ Join our [mailing list](https://lists.r-consortium.org/g/RConsortium-Validation-Hub)! (pharmaR.org > Contact Us)
:::
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![](resources/linkedIn-logo.png){height="160"}
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![](resources/contact_us.png){style="border-color:black; border-style:solid; border-width:0.25em;"}

## 🚧 Website: `pharmaR.org` THEN

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## 🆕 Gathering GxP Package Lists

<br>

- **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


::::


## 🆕 Open-sourced Package List

::: {style="margin-left:1em; padding-top:1em"}
### 🔗 [insightsengineering.github.io/rvalidationhub-packages/](https://insightsengineering.github.io/rvalidationhub-packages/)
:::


![](resources/pkg-lists-roche.png){style="margin-left:3em; padding-top:1em;"}



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# 🗓️ 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}
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