Panel Discussion

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

Description

Following the 2 talks, a panel comprised of experts from FDA and pharmaceutical industry will share their thoughts on how we embrace software and methodology innovation while ensuring quality. The panel will also address questions from the audience.

Keywords

Open source

statistical software

software engineering

high-quality R packages

cross-company collaboration

regulatory considerations 

Presenting Author(s)

Daniel Sabanes Bove, Roche
Eric Nantz, Eli Lilly and Company
Paul Schuette, FDA/CDER
Tae Hyun Jung, FDA