In the rapidly evolving landscape of pharmaceutical development, Roche showcases the use of open-source R in the regulatory submission process. In this webinar, the Roche team will share a pioneering experience of end-to-end R submission for a new drug application to the FDA, EMA, and NMPA.

Learn how a team at Roche successfully used R, including open-source packages from the pharmaverse, to support a complete New Drug Application (NDA) submission. They share practical lessons from building a regulatory submission pipeline entirely in R and working closely with health authorities throughout the process.

Key topics covered include:
• How the team addressed early challenges with clinical data and submission workflows
• Using R to clean, analyze, and visualize clinical trial data
• Building a complete eSubmission package within a validated R environment
• Communicating and collaborating with regulatory agencies
• Ensuring R-generated outputs were accepted and validated as part of the submission
• Demonstrating how open-source tools, primarily from the pharmaverse, can support high-stakes regulatory work
• This webinar offers a detailed look at how open source is being applied in real-world regulatory submissions.