Planning 2024

[jmanitz]

Company-specific community meetings:

• Biogen (Anuja), A/Z (Antal), Cetara (Antal), EMD Serono (Juliane)
• Ask others in the executive committee (Juliane)
• Contact case studies presenters (Anuja)
• What to present: Prepare a standard slide deck and combine with company specific efforts
• Pitch at the community leader group (Anuja)

Conferences

• Pharmacometrics conferences: PAGE (26-28 June, Rome. Abstract submission DL: March 17th), ACOP (Antal)
• R/Pharma, Posit::conf,
• useR! 2024 will be a hybrid conference, taking place 8-11 July 2024 in Salzburg, Austria. (Juliane/Antal)
• Posit data science hangout (Anuja)
• PharmaSUG (Abstract submission Jan 15, Anuja)
• JSM (deadline Feb 1st), ASA BIOP (deadline March 28, Juliane)
• Phuse Webinar / connect 2025 (Anuja)
• PSI, others?

Community meetings:

• Organization idea: Breakout rooms for discussion with one member exec/comms member present, then bring conclusion back to the main meeting
• General validation topic: What does the term “validation” mean in different contexts?
• Revisiting the case studies: Where are they now
• Workstreams: riskmetric/riskassessment, repo updates
• Every three months starting around mid Feb 15, May 15, ...

[antalmartinecz]

Added dates to the PAGE conference

[yannfeat]

As the pharmaR/regulatory-r-repo-wg is moving forward with the implementation of a validation pipeline, we agree with @dgkf that it would be a good idea for me to showcase our current work in a talk. I am thinking about useR! 2024 (20-minute session), but it could take place at PHUSE EU Connect 2024 (10–13 November in Strasbourg, France) instead.

What do you think?

[jmanitz]

@antalmartinecz @dgkf Can you review the draft for the JSM abstract?
https://github.com/pharmaR/events/blob/main/JSM_2024/abstract_submission.txt

I hope its okay that I simplified the author list to potential presenters...

[dgkf]

Just some minor edits from me. No real content changes, just editing to make it read more naturally. If we have a bit more space, I'd perhaps add some more context about the reach of the R Validation Hub (number of participating companies).

This contribution reflects on framework and tools by the R Validation Hub for risk-based assessment of R packages within a validated infrastructure.
The R Validation Hub is a cross-industry initiative funded by the R Consortium, that to supports the adoption of R within a biopharmaceutical regulatory setting regulated industries, with an emphasis on biopharmaceuticals.
We will discuss the framework for the risk-based assessment of R packages, that has been utilized by key pharma companies across the industry.
We will also showcase the {riskmetric} R package, that evaluates the risk of an R package using a specified set of metrics and validation criteria, and
the {riskassessment} app, that augments the utility of the {riskmetric} package within a Shiny app front end.
Lastly, we will outline a prototype of a technical framework for a 'repository' of R packages with accompanying evidence of their quality and the assessment criteria.
Although, our work has mostly focused in biopharmaceutical, it may also be relevant in other regulated areas such as financial service industries and agriculture.

And if you agree with these suggestions, here would be the resulting text:

This contribution reflects on framework and tools by the R Validation Hub for risk-based assessment of R packages within validated infrastructure.
The R Validation Hub is a cross-industry initiative funded by the R Consortium, that to supports the adoption of R within regulated industries, with an emphasis on biopharmaceuticals.
We will discuss the framework for the risk-based assessment of R packages, that has been utilized by key pharma companies across the industry.
We will also showcase the {riskmetric} R package, that evaluates the risk of an R package using a specified set of metrics and validation criteria, and
the {riskassessment} app, that augments the utility of the {riskmetric} package with a Shiny app front end.
Lastly, we will outline a prototype of a technical framework for a 'repository' of R packages with accompanying evidence of their quality and the assessment criteria.

[jmanitz]

Great, thanks for your feedback. I made the suggested changes and submitted the abstract, see https://github.com/pharmaR/events/blob/main/JSM_2024/JSMsubmission.pdf