Abstract: In the rapidly evolving landscape of pharmaceutical development, Roche showcases the use of open source R in the regulatory submission process. In this presentation we will share a pioneer experience of end-to-end R submission for a new drug application to FDA, EMA and NMPA.  The successful end-to-end NDA submission using R packages, the majority being open source packages (from pharmaverse), not only demonstrates the feasibility and benefits of leveraging such a powerful tool in the regulatory realm but also sets a precedent for its wider adoption in the pharmaceutical industry.
Speaker: Ning Leng
Affiliation: Genentech
Title: Roche’s first end-to-end R submission
Abstract_Sanitzed: In the rapidly evolving landscape of pharmaceutical development, Roche showcases the use of open source R in the regulatory submission process. In this presentation we will share a pioneer experience of end-to-end R submission for a new drug application to FDA, EMA and NMPA.  The successful end-to-end NDA submission using R packages, the majority being open source packages (from pharmaverse), not only demonstrates the feasibility and benefits of leveraging such a powerful tool in the regulatory realm but also sets a precedent for its wider adoption in the pharmaceutical industry.