Open Source Technologies in Regulatory Submissions

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Abstract

While interoperability and standardization have been goals of the pharmaceutical data science industry for years, much of the work to create and validate a submission package is done manually or with proprietary software. Integrating tabular study data, study metadata, STF data, and visualizations are low-hanging fruit for a collaborative industry solution. Open-source tools have matured in their reliability and flexibility. This <paper/poster> will explore their emerging use in regulatory submissions. The topics of tools that assist in creating a submission package, the cost of these tools, and the necessary controls and validation need to create and maintain a complaint eCTD package will be discussed.

Team Members

  • Eli Miller
  • James Gunter
  • Michael Stackhouse
  • Frank Menius
  • Michael Rimler
  • Gayathri Kolandaivelu

Relevant Documents

ICH

eCTD Specification

FDA

FDA VENCLEXTA Submission - R used in pharmacometric statistical and graphical review

FDA Cinvanti Submission - R used in Bioequivalence and PK review

FDA Technical Rejection Criteria

FDA Technical Conformance Guide

FDA TRC 2019 Report

r-project

Regulatory Compliance and Validation Issues

Existing Tools

Define Editor

R Package: xml2

Python Package: XML

CDISC

Define-XML standard