Open-source software for regulatory submissions and regulatory environments

Conference: ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2023
09/29/2023: 1:30 PM - 2:45 PM EDT
Parallel 

Description

Regulatory submissions and regulatory computing environments have traditionally been associated with the use of proprietary software packages. While academic institutions have embraced open-source software, both industry and government have been slower to adopt open-source alternatives. I will discuss some of the challenges and issues with using open-source software in a regulatory environment, followed by some of the lessons learned in the ongoing R Consortium R Submission Pilot, as well as emerging issues.

Keywords

open-source

software

statistical computing 

Presenting Author

Paul Schuette, FDA/CDER