Drug Evaluation Committee April 2, 2025 Workshop on "The Actual Use and Future Prospects of Open Source Software "R" in Drug Submission Processes
Jun 18, 2025
We are pleased to host the above-mentioned workshop.
In recent years, an increasing number of pharmaceutical companies have been using open source software "R" for analyzing clinical trial data in order to file for approval. In this workshop, we shared and discussed through presentations and panel discussions how R is being used, how the increasing use of R will change their business, and what they should pay attention to in doing so.
In this workshop, in addition to the introduction of examples of R use by the Data Science Subcommittee Task Force members, the R Consortium's pilot application to the FDA and Roche's R efforts were introduced from overseas, and the Japan CRO Association presented the current status of R efforts in CROs. The Japan CRO Association also invited external speakers to speak on the current status of R initiatives at CROs.
We are pleased to publish the presentation materials of the day's presentations, which have been kindly made available by the external speakers, below.