Roche's End-to-End R Journey to Submission

In the rapidly evolving landscape of pharmaceutical development, Roche showcases the use of open-source R in the regulatory submission process.

In this web event, 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.

They will unfold the journey of overcoming the initial challenges to achieving the filing goal and emphasize the practicalities of processing, analyzing, and visualizing clinical trial data in R, leading to a comprehensive eSubmission package.

They will also share our strategic communication and collaboration with regulatory agencies, highlighting how R-generated data and documentation were effectively presented and validated within the submission framework. The successful end-to-end NDA submission using R packages, the majority of which are open-source packages (from pharmaverse), demonstrates the feasibility and benefits of leveraging such a powerful tool in the regulatory realm and sets a precedent for its wider adoption in the pharmaceutical industry.

More about Posit in Pharma: https://posit.co/solutions/pharma/

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