From 81e02aa523a830d6bc5ac52fed2992775667fe3c Mon Sep 17 00:00:00 2001
From: dgkf <18220321+dgkf@users.noreply.github.com>
Date: Tue, 24 Oct 2023 10:49:06 -0400
Subject: [PATCH] initial commit
---
.github/workflows/quarto.yml | 28 +
.gitignore | 1 +
README.md | 16 +
_extensions/pharmaR/rvalhub/_extension.yml | 54 +
_extensions/pharmaR/rvalhub/assets/logo.svg | 162 +++
.../pharmaR/rvalhub/assets/logo_small.svg | 83 ++
.../rvalhub/assets/swirling-margins.svg | 62 ++
_extensions/pharmaR/rvalhub/custom-dark.scss | 49 +
_extensions/pharmaR/rvalhub/custom-light.scss | 42 +
_extensions/pharmaR/rvalhub/custom.scss | 63 ++
_quarto.yml | 4 +
_r_val_hub_intro.qmd | 157 +++
_r_val_hub_repo.qmd | 247 +++++
_r_val_hub_updates.qmd | 108 ++
assets/CAMIS-white-paper.png | Bin 0 -> 160791 bytes
assets/camis.png | Bin 0 -> 34590 bytes
assets/r-consortium.png | Bin 0 -> 24117 bytes
assets/repository-diagram.svg | 954 ++++++++++++++++++
assets/riskassessment-file-browser.png | Bin 0 -> 87890 bytes
assets/riskassessment.png | Bin 0 -> 107935 bytes
assets/riskmetric.png | Bin 0 -> 112224 bytes
assets/rvalhub-comm-channels.svg | 3 +
index.qmd | 410 ++++++++
23 files changed, 2443 insertions(+)
create mode 100644 .github/workflows/quarto.yml
create mode 100644 .gitignore
create mode 100644 README.md
create mode 100644 _extensions/pharmaR/rvalhub/_extension.yml
create mode 100644 _extensions/pharmaR/rvalhub/assets/logo.svg
create mode 100644 _extensions/pharmaR/rvalhub/assets/logo_small.svg
create mode 100644 _extensions/pharmaR/rvalhub/assets/swirling-margins.svg
create mode 100644 _extensions/pharmaR/rvalhub/custom-dark.scss
create mode 100644 _extensions/pharmaR/rvalhub/custom-light.scss
create mode 100644 _extensions/pharmaR/rvalhub/custom.scss
create mode 100644 _quarto.yml
create mode 100644 _r_val_hub_intro.qmd
create mode 100644 _r_val_hub_repo.qmd
create mode 100644 _r_val_hub_updates.qmd
create mode 100644 assets/CAMIS-white-paper.png
create mode 100644 assets/camis.png
create mode 100644 assets/r-consortium.png
create mode 100644 assets/repository-diagram.svg
create mode 100644 assets/riskassessment-file-browser.png
create mode 100644 assets/riskassessment.png
create mode 100644 assets/riskmetric.png
create mode 100644 assets/rvalhub-comm-channels.svg
create mode 100644 index.qmd
diff --git a/.github/workflows/quarto.yml b/.github/workflows/quarto.yml
new file mode 100644
index 0000000..53d736d
--- /dev/null
+++ b/.github/workflows/quarto.yml
@@ -0,0 +1,28 @@
+on:
+ push:
+ branches: main
+
+name: Render and Publish
+
+jobs:
+ build-deploy:
+ runs-on: ubuntu-latest
+ steps:
+ - name: Check out repository
+ uses: actions/checkout@v3
+
+ - name: Set up Quarto
+ uses: quarto-dev/quarto-actions/setup@v2
+ with:
+ # To install LaTeX to build PDF book
+ tinytex: true
+ # uncomment below and fill to pin a version
+ # version: SPECIFIC-QUARTO-VERSION-HERE
+
+ - name: Publish to GitHub Pages (and render)
+ uses: quarto-dev/quarto-actions/publish@v2
+ with:
+ target: gh-pages
+ env:
+ GITHUB_TOKEN: ${{ secrets.GITHUB_TOKEN }} # this secret is always available for github actions
+
\ No newline at end of file
diff --git a/.gitignore b/.gitignore
new file mode 100644
index 0000000..075b254
--- /dev/null
+++ b/.gitignore
@@ -0,0 +1 @@
+/.quarto/
diff --git a/README.md b/README.md
new file mode 100644
index 0000000..a69e7d9
--- /dev/null
+++ b/README.md
@@ -0,0 +1,16 @@
+# R/Pharma 2023 conference
+
+The R Validation Hub was invited to give a 20min presentation workshop highlighting
+recent activities and share our future direction.
+
+## Take a peek
+
+[Slides are hosted on GitHub pages](https://pharmar.github.io/events-rpharma2023)
+
+## Building the deck
+
+Build the slides in terminal with
+
+```
+quarto preview
+```
\ No newline at end of file
diff --git a/_extensions/pharmaR/rvalhub/_extension.yml b/_extensions/pharmaR/rvalhub/_extension.yml
new file mode 100644
index 0000000..df258f4
--- /dev/null
+++ b/_extensions/pharmaR/rvalhub/_extension.yml
@@ -0,0 +1,54 @@
+title: rvalhub
+author: dgkf
+version: 1.0.0
+quarto-required: ">=1.2.0"
+contributes:
+ formats:
+ revealjs:
+ # general
+
+ self-contained: true
+ theme: [default, custom.scss, custom-light.scss]
+ template-partials:
+ - revealjs-assets/title-slide.html
+
+ # code
+ highlight-style: arrow
+ code-line-numbers: true
+ code-annotations: hover
+
+ # assets
+ logo: assets/logo.svg
+ background-image: assets/swirling-margins.svg
+
+ revealjs+light:
+ # general
+ self-contained: true
+ theme: [default, custom.scss, custom-light.scss]
+ template-partials:
+ - revealjs-assets/title-slide.html
+
+ # code
+ highlight-style: arrow
+ code-line-numbers: true
+ code-annotations: hover
+
+ # assets
+ logo: assets/logo.svg
+ background-image: assets/swirling-margins.svg
+
+ revealjs+dark:
+ # general
+ self-contained: true
+ theme: [dark, custom.scss, custom-dark.scss]
+ template-partials:
+ - revealjs-assets/title-slide.html
+
+ # code
+ highlight-style: ayu
+ code-line-numbers: true
+ code-annotations: hover
+
+ # assets
+ logo: assets/logo.svg
+ background-image: assets/swirling-margins.svg
diff --git a/_extensions/pharmaR/rvalhub/assets/logo.svg b/_extensions/pharmaR/rvalhub/assets/logo.svg
new file mode 100644
index 0000000..e26730b
--- /dev/null
+++ b/_extensions/pharmaR/rvalhub/assets/logo.svg
@@ -0,0 +1,162 @@
+
+
+
+
diff --git a/_extensions/pharmaR/rvalhub/assets/logo_small.svg b/_extensions/pharmaR/rvalhub/assets/logo_small.svg
new file mode 100644
index 0000000..cb8fa36
--- /dev/null
+++ b/_extensions/pharmaR/rvalhub/assets/logo_small.svg
@@ -0,0 +1,83 @@
+
+
+
+
diff --git a/_extensions/pharmaR/rvalhub/assets/swirling-margins.svg b/_extensions/pharmaR/rvalhub/assets/swirling-margins.svg
new file mode 100644
index 0000000..94ddd03
--- /dev/null
+++ b/_extensions/pharmaR/rvalhub/assets/swirling-margins.svg
@@ -0,0 +1,62 @@
+
\ No newline at end of file
diff --git a/_extensions/pharmaR/rvalhub/custom-dark.scss b/_extensions/pharmaR/rvalhub/custom-dark.scss
new file mode 100644
index 0000000..44a6b78
--- /dev/null
+++ b/_extensions/pharmaR/rvalhub/custom-dark.scss
@@ -0,0 +1,49 @@
+/*-- scss:defaults --*/
+$tippy-border: rgb(64, 64, 64);
+
+/*-- scss:rules --*/
+.reveal {
+ .slide-logo {
+ filter: drop-shadow(0px 3px 2px #0006);
+ }
+
+ .code-copy-button {
+ filter: brightness(0%) invert(100%) opacity(30%);
+ }
+
+ .code-copy-button:hover {
+ filter: brightness(0%) invert(80%) opacity(90%);
+ }
+
+ .code-annotation-anchor {
+ filter: brightness(0%) invert(100%) opacity(30%);
+ }
+
+ .cell {
+ // console code output
+ .cell-output pre {
+ background-color: rgba(0, 0, 0, 0.5);
+ }
+ }
+
+ // code annotation hover box
+ .tippy-box[data-theme~="light-border"] {
+ border-color: $tippy-border;
+ }
+
+ .tippy-box[data-theme~="light-border"][data-placement^="top"] > .tippy-arrow::before {
+ border-top-color: $tippy-border;
+ }
+
+ .tippy-box[data-theme~="light-border"][data-placement^="right"] > .tippy-arrow::before {
+ border-right-color: $tippy-border;
+ }
+
+ .tippy-box[data-theme~="light-border"][data-placement^="bottom"] > .tippy-arrow::before {
+ border-bottom-color: $tippy-border;
+ }
+
+ .tippy-box[data-theme~="light-border"][data-placement^="left"] > .tippy-arrow::before {
+ border-left-color: $tippy-border;
+ }
+}
\ No newline at end of file
diff --git a/_extensions/pharmaR/rvalhub/custom-light.scss b/_extensions/pharmaR/rvalhub/custom-light.scss
new file mode 100644
index 0000000..e1f6719
--- /dev/null
+++ b/_extensions/pharmaR/rvalhub/custom-light.scss
@@ -0,0 +1,42 @@
+/*-- scss:defaults --*/
+$primary: #4d8dc9;
+$secondary: #68b8e5;
+
+$presentation-heading-color: $primary;
+
+$tippy-border: rgb(200, 200, 200);
+
+/*-- scss:rules --*/
+.reveal {
+ .slide-logo {
+ filter: drop-shadow(0px 0px 3px #FFF);
+ }
+
+ .cell {
+ // console code output
+ .cell-output pre {
+ background-color: rgba(210, 220, 230, 0.6);
+ }
+ }
+
+ // code annotation hover box
+ .tippy-box[data-theme~="light-border"] {
+ border-color: $tippy-border;
+ }
+
+ .tippy-box[data-theme~="light-border"][data-placement^="top"] > .tippy-arrow::before {
+ border-top-color: $tippy-border;
+ }
+
+ .tippy-box[data-theme~="light-border"][data-placement^="right"] > .tippy-arrow::before {
+ border-right-color: $tippy-border;
+ }
+
+ .tippy-box[data-theme~="light-border"][data-placement^="bottom"] > .tippy-arrow::before {
+ border-bottom-color: $tippy-border;
+ }
+
+ .tippy-box[data-theme~="light-border"][data-placement^="left"] > .tippy-arrow::before {
+ border-left-color: $tippy-border;
+ }
+}
\ No newline at end of file
diff --git a/_extensions/pharmaR/rvalhub/custom.scss b/_extensions/pharmaR/rvalhub/custom.scss
new file mode 100644
index 0000000..3899c87
--- /dev/null
+++ b/_extensions/pharmaR/rvalhub/custom.scss
@@ -0,0 +1,63 @@
+/*-- scss:defaults --*/
+$primary: #4d8dc9;
+$secondary: #68b8e5;
+
+$presentation-title-slide-text-align: left;
+$link-color: $primary;
+$code-block-bg: rgba(lighten($primary, 20%), 0.1);
+$code-block-border-color: transparent;
+
+/*-- scss:rules --*/
+.reveal {
+ .slide-logo {
+ max-height: 12.5vh !important;
+ max-width: 20vw !important;
+ }
+
+ .backgrounds {
+ background-size: cover;
+ background-position-y: center;
+ }
+
+ .slide-logo-title {
+ visibility: hidden;
+ }
+
+ .cell {
+ // echo'ed code blocks
+ .sourceCode {
+ background-color: transparent;
+
+ // only blur and apply colors to code-containing div, otherwise we blur the text as well
+ pre {
+ background-color: rgba($primary, 0.1);
+ backdrop-filter: blur(10px);
+ }
+
+ // line number gutters
+ span > a::before {
+ background-color: rgba($primary, 0.1);
+ }
+ }
+
+ // console code output
+ .cell-output pre {
+ background-color: rgba(0, 0, 0, 0.5);
+ backdrop-filter: blur(10px);
+
+ code {
+ background-color: transparent;
+ }
+ }
+
+ // filename line
+ .code-with-filename-file {
+ background-color: rgba($primary, 0.2);
+ backdrop-filter: blur(10px);
+
+ pre {
+ background-color: transparent;
+ }
+ }
+ }
+}
\ No newline at end of file
diff --git a/_quarto.yml b/_quarto.yml
new file mode 100644
index 0000000..eeba69a
--- /dev/null
+++ b/_quarto.yml
@@ -0,0 +1,4 @@
+project:
+ title: "R Validation Hub at posit::conf(2023)"
+
+format: rvalhub-revealjs
diff --git a/_r_val_hub_intro.qmd b/_r_val_hub_intro.qmd
new file mode 100644
index 0000000..e673f85
--- /dev/null
+++ b/_r_val_hub_intro.qmd
@@ -0,0 +1,157 @@
+# π Who We Are {transition="none-in slide-out"}
+
+```{=html}
+
+```
+
+::: { style="font-size: 0.7em;" }
+> The ***R Validation Hub*** is a collaboration to support the adoption of R
+> within a biopharmaceutical regulatory setting ([pharmaR.org](https://www.pharmaR.org))
+:::
+
+* Grew out of **R/Pharma 2018**
+* Led by participants from **~10 organizations**
+* R Consortium Working Group
+* With frequent involvement from health authorities (primarily the FDA)
+* And subscribers from **~60 organizations** spanning multiple industries
+
+## π€ Affiliates: {height="1.2em" style="padding: 0.2em; margin: 0 0.5em 0 0; border-radius: 0.8em; background: #FFF; vertical-align: middle;"} [R Consortium]{.hidden} {transition="slide-in slide-out"}
+
+::: {style="font-size: 0.7em"}
+> Works with and provides support to the R Foundation and to the key
+> organizations developing, maintaining, distributing and using R software
+:::
+
+* The R Validation Hub
+* R Submission Working Group
+* R Repositories Working Group (ie CRAN enhancements, future development)
+
+
+## π€ Affiliates: {height="1.2em" width="1.2em" style="margin: 0 0.2em; border-radius: 50%; object-fit: cover; background: #CBC; vertical-align: middle;"} PSI/AIMS (CAMIS) {transition="slide-in slide-out"}
+
+::::: {.columns}
+:::: {.column width="65%"}
+::: { style="font-size: 0.6em;" }
+> **C**omparing **A**nalysis **M**ethod **I**mplementations in **S**oftware
+> A cross-industry group formed of members from PHUSE, PSI, and ASA.
+:::
+
+::: { style="font-size: 0.7em;" }
+- Released a [white paper](https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Data+Visualisation+%26+Open+Source+Technology/WP077.pdf) providing guidance on appropriate use of stats methods, for example:
+ * Don't default to the defaults
+ * Be specific when drafting analysis plans, including precise methods & options
+- Currently building a repository of methods comparisons at
+ [psiaims.github.io/CAMIS](https://psiaims.github.io/CAMIS/).
+- Check out their
+ [contributors page](https://psiaims.github.io/CAMIS/contribution.html) to
+ learn how you can get involved!
+:::
+::::
+:::::
+
+## π·ββοΈ What We Do ([pharmaR.org](https://www.pharmaR.org)) {transition="slide-in slide-out"}
+
+
+
+::::: {.columns}
+:::: {.column width="29%" .panel}
+#### White Paper
+Guidance on compliant use of R and management of packages
+
+::: {.person}
+Andy Nicholls et al.
+:::
+::::
+
+:::: {.column width="29%" .panel}
+#### [New!]{.badge-pill} Repositories
+
+Building a public, validation-ready resource for R packages
+
+::: {.person}
+Coline Zeballos
+:::
+::::
+
+:::: {.column width="29%" .panel}
+#### [New!]{.badge-pill} Communications
+
+Connecting validation experts across the industry
+
+::: {.person}
+Juliane Manitz
+:::
+::::
+:::::
+
+::::: {.columns}
+:::: {.column width="29%" .panel}
+#### [`{riskmetric}`](https://github.com/pharmaR/riskmetric)
+
+Gather and report on risk heuristics to support validation decision-making
+
+::: {.person}
+Eric Milliman
+:::
+::::
+
+:::: {.column width="29%" .panel}
+#### [`{riskassessment}`](https://github.com/pharmaR/riskassessment)
+
+A web interface to `{riskmetric}`, supporting review,
+annotation and cataloging of decisions
+
+::: {.person}
+Aaron Clark
+:::
+::::
+
+:::: {.column width="29%" .panel}
+#### [New!]{.badge-pill} [`{riskscore}`](https://github.com/pharmaR/riskscore)
+
+An R data package capturing risk metrics across all of CRAN
+
+::: {.person}
+Aaron Clark
+:::
+::::
+:::::
+
+
diff --git a/_r_val_hub_repo.qmd b/_r_val_hub_repo.qmd
new file mode 100644
index 0000000..e62438d
--- /dev/null
+++ b/_r_val_hub_repo.qmd
@@ -0,0 +1,247 @@
+
+# π¦ Repositories
+
+## Repositories Workstream
+
+::: { style="font-size: 0.8em;" }
+> Supporting a transparent, open, dynamic, cross-industry approach of
+> establishing and maintaining a _repository_ of R packages.
+
+* Taking ample time to engage stakeholders
+ * Validation leads across the industry
+ * Active health authority involvement
+ * Analytic environment admins and developers
+* Considering the possibilities
+ * Mapping needs to solutions that meet the industry where it is
+ * ...while building the path for it to move forward
+:::
+
+
+## How did we get here?
+
+::: {.incremental style="font-size: 0.8em;"}
+* [Our whitepaper is widely adopted]{.fragment .semi-fade-out}
+* [But implementing it is inconsistent & laborious]{.fragment .semi-fade-out}
+ * [Variations throughout industry pose uncertainty]{.fragment .semi-fade-out}
+ * [Sharing software with health authorities is a challenge]{.fragment .semi-fade-out}
+ * [Health authorities, overwhelmed by technical inconsistencies, are more likely to question software use]{.fragment .semi-fade-out}
+* We feel the most productive path forward is a shared ecosystem
+:::
+
+::: {.notes}
+- **inconsistent**: Vendored choices inevitably face inconsistency when
+ merged with internally developed tools
+- **sharing**: `pkglite`, `.R` files now permitted, Hosting on git repo/r-universe? But comes with extra install steps.
+- **laborious**: We're all reviewing the same tools, duplicating effort and
+:::
+
+
+## Work to-date
+
+**Building consensus in package evaluation and distribution...**
+
+0. Who needs a repository anyways?
+1. Stakeholder engagement [3mo]{.dim}
+2. Product refinement and proof-of-concept planning [1mo]{.dim}
+3. POC development [2mo]{.dim}
+
+
+## β Hold up! Why a repository?
+
+> "Every successful team starts with a small existential crisis"
+> -- _unknown_
+
+- Tools for building evaluation in-house?
+- Sharing of extra testing resources?
+- Curation of packages?
+- A stricter CRAN?
+
+
+## Interesting Stakeholder Findings
+
+- Health authority primary concerns
+ - Avoiding **security vulnerabilities** while using R
+ - Visible discussions **vetting methodology** and relevance
+- Industry validation leads
+ - Relieved that open-source tools are public, less need to audit
+ vendored tools
+- System administrators, users and developers
+ - Want **clarity** and **consistency** internally and externally
+
+
+## Prototyping
+
+Running three prototypes to explore specific needs
+
+- Test case exchange format ([repo](https://github.com/kkmann/rmes/pulls))
+- Communication channels for methods discussion & considerations ([google doc](https://docs.google.com/presentation/d/1b9VZjVM1pzzSmrO7WFKK43EjBZMT0smRrNY_0BPSR0s/edit#slide=id.g1e4f3a104ee_0_0))
+- Risk filters and transparency of known vulnerabilities ([repo](https://github.com/dgkf/rvalhub-repo-filters-mvp))
+
+
+## Prototyping
+### Test Case Exchange Format
+
+```json
+{
+ "rPackage": {
+ "name": "stats",
+ "link": "https://cran.r-project.org/package=stats"
+ },
+ "CSADocPkg": {
+ "function": {
+ "name": "t.test",
+ "assuranceActivity": {
+ "activityType": "Scripted Testing: Robust",
+ "definition": "Scripted testing efforts in which the risk of the computer system or automation includes evidence of repeatability, traceability to requirements, and auditability.",
+ "parameters": {
+ "testObjectives": [
+ {
+ "uuid": "6cde1b0f-3e41-4878-8cd5-79c87be88a7d",
+ "objective": "Verify that p values produced by stats::t.test are uniformly distributed",
+ "keywords": ["t.test", "p values", "uniform distribution"],
+ "testCases": [
+ {
+ "uuid": "4fa03a8d-2e39-4866-9cd3-69b77bd78a6b",
+ "testName": "t test produces calibrated p values",
+ "description": "This test checks that the p values produced by stats::t.test do not deviate substantially from the expected uniform distribution.",
+ "code": "set.seed(42)\\nm <- 100\\nfor (n in c(5, 50, 500)) {\\n# repeatedly sample data under null and record p value\\nres <- numeric(m)\\nfor (i in 1:m) {\\nres[i] <- t.test(rnorm(n))$p.value\\n}\\n# expect non significant result\\nexpect_true(\\nks.test(res, 'punif')$p.value > 0.05\\n)\\n}",
+ "result": "pass",
+ "environment": {
+ "container": "rocker/tidyverse:4.3.1",
+ "runtime": "singularity",
+ "runtimeVersion": "3.8",
+ "renvLockfile": ""
+ }
+ }
+ ...
+```
+
+## Prototyping
+### Communication Channels
+
+
+
+
+## Prototyping
+### Package Security & Risk Filters
+
+```r
+install.packages("options")
+#> Security vulnerabilities found in packages to be installed.
+#> To proceed with installation, re-run with `accept_vulnerabilities = TRUE`
+#>
+#> ββ Vulnerability overview ββ
+#>
+#> βΉ 1 package was scanned
+#> βΉ 1 package was found in the Sonatype database
+#> βΉ 1 package had known vulnerability
+#> βΉ A total of 1 known vulnerability was identified
+#> βΉ See https://github.com/sonatype-nexus-community/oysteR/ for details.
+```
+
+```r
+nrow(available.packages())
+#> 5 "low risk" packages
+
+options(available_packages_filters = NULL)
+nrow(available.packages())
+#> 17 available packages
+```
+
+
+## A fork in the road
+
+Given the key capabilities and tools to address them. How do we bundle
+these solution to address industry needs?
+
+:::: {.columns style="font-size: 0.7em;"}
+::: {.column .fragment width="50%"}
+**Support our industry today**
+
+> _Delivering in-house solutions for you to pick-and-choose_
+
+- Consistent processes to apply
+- Local tools to deploy in-house
+- Community forum for knowledge sharing
+:::
+
+::: {.column .fragment width="50%"}
+**Build what we want the industry to be**
+
+> _Drive change through transparency and consistency_
+
+- Lead by example with a public solution
+- Make it easier to adopt than re-build
+- Transparency-first solutions
+:::
+::::
+
+
+## What does a solution look like? {visibility="hidden"}
+
+::: {.callout-note}
+## If it's not broke, don't fix it!
+:::
+
+::: {.incremental style="font-size: 0.8em;"}
+- R has this wonderful thing called CRAN, setting the standard of quality
+ - Packages are constantly tested together
+ - R has a culture of amazing documentation
+ - Statisticians flock to R, and are constantly vetting its implementations
+:::
+
+
+## What does a solution look like? {visibility="hidden"}
+::: {.callout-warning}
+## Fool me twice, shame on me
+:::
+
+::: {.incremental style="font-size: 0.8em;"}
+- R has this thorn in its side called CRAN,
+ - Builds are difficult to reproduce (key for validation)
+ - Quality indicators are lacking
+ - Difficult to roll back to an older snapshot (although tools exist to help with this.)
+ - Governance isn't always the most friendly
+:::
+
+
+## What does a solution look like?
+
+::: {.callout-tip}
+## Closing the CRAN gap for the Pharma Use Case
+:::
+
+- Reproducibility guidelines
+- Standard, public assessment of packages
+- Avenues for communicating about implementations, bugs, security
+
+
+## The Proposal so Far
+
+{.r-stretch .center style="display: block; margin: auto"}
+
+## π§ "Leaps of Faith"
+
+```{=html}
+
+```
+
+- [***A "Golden" Base Image***]{.highlight}
+ to establish ground truth for testing.
+- [***Rethinking requirements***]{.highlight}
+ testing, external vetting (CRAN) and adoption are sufficient for _Scripted
+ Testing_ needs - are new requirements necessary?
+- [***Expectations of Public Communication***]{.highlight}
+ industry-standard communication channels.
+- [***Nearly all meaningful assessment can be automated***]{.highlight}
+ edge cases (malicious code, methods debate) are better handled by
+ transparent community engagement.
+
+## The Proposal so Far
+
+{.r-stretch .center style="display: block; margin: auto"}
+
diff --git a/_r_val_hub_updates.qmd b/_r_val_hub_updates.qmd
new file mode 100644
index 0000000..562c1a7
--- /dev/null
+++ b/_r_val_hub_updates.qmd
@@ -0,0 +1,108 @@
+---
+editor:
+ markdown:
+ wrap: 72
+---
+
+# π£ Updates {transition="slide-in none"}
+
+## π Key Policy Updates!
+
+> If nothing else, take this home!
+
+- The FDA appears to accept `.R` files through their eSUB portal[^1] .
+- The FDA has released a draft of a new *Computer Software
+ Assurance*[^2] guideline that seems to be increasingly the basis for
+ their evaluation of R.
+
+[^1]: [R Consortium R Submission WG, Pilot
+ #1](https://github.com/RConsortium/submissions-pilot1)
+
+[^2]: [*Computer Software Assurance for Production and Quality Systems
+ Software: Draft Guidance for Industry and Food and Drug
+ Administration Staff*](https://www.fda.gov/media/161521/download)
+
+## Change of Leadership
+
+- We thank Andy for his leadership and enthusiasm that brought the R
+ Validation Hub to this point.
+- New R validation hub lead is Doug Kelkhoff
+
+### Pulse Check
+
+
+
+- Identified new opportunities
+ 1. Refining holistic strategic direction
+ 2. Be mindful about communication and organization
+- We have a new Communication workstream! (and awesome new slides!)
+- More ways to get involved
+
+# π Workstream Report
+
+## [Case Studies](https://www.pharmar.org/casestudies/)
+
+> 7 Companies Shared their Approach to Package Validation
+
+::: {.columns style="font-size: 0.7em;"}
+::: {.column width="33%"}
+#### Commonalities
+
+- Categorized risk (hi/med/lo)
+- Heavily weight unit testing
+- Base & Suggested packages "trusted"
+:::
+
+::: {.column width="33%"}
+#### Differences
+
+- Risk stratification (eg coverage cutoff)
+- Managing risk
+ - human-in-the-middle review
+ - restricted package subset
+ - adding bespoke testing
+:::
+
+::: {.column width="33%"}
+#### Themes
+
+- Time & resource intensive
+- Requires unique intersection of expertise
+- **Challenges of lifecycle management of ecosystem**
+:::
+:::
+
+## {height="1.8em" width="1.8em" style="margin: 0 0.2em; object-fit: contain;vertical-align: middle;"} `{riskmetric}` Roadmap
+
+::: {style="font-size:0.8em"}
+- **Ease of use:**\
+ Wrapper functions for a a complete workflow, prettier outputs
+- **Metric completeness:**\
+ Implement metrics for as many pacakge sources as possible. Chain
+ sources together to create more complete assessments
+- **Modular addititions:**\
+ Allow users to easy add custom assessments, create optional
+ assessments based on community packages (e.g. `oyster`, `srr`,
+ `pkgstats`, etc)
+- **Focusing on metrics and scoring:**\
+ Making custom weighting more robust and convenient. Guidance
+ materials on weighting specific assessments based on community
+ feedback and our own views on best practices.
+:::
+
+## {height="1.8em" width="1.8em" style="margin: 0 0.2em; object-fit: contain;vertical-align: middle;"} `{riskassessment}` App
+
+### Feature Recap
+
+- Face lifts for *Report Builder* & *Database View*
+- Better dependency inspection
+- Org-level customizations using config file
+- Allow `admin` user role management
+- Package file explorer
+
+## {height="1.8em" width="1.8em" style="margin: 0 0.2em; object-fit: contain;vertical-align: middle;"} `{riskassessment}` App
+
+#### New Test explorer! (Code provided by *GSK*)
+
+{.r-stretch .center
+style="display: block; margin: auto;"}
diff --git a/assets/CAMIS-white-paper.png b/assets/CAMIS-white-paper.png
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