Open Source Technologies for Regulatory Submissions
Project Scope |
While interoperability and standardisation 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 visualisations are low-hanging fruit for a collaborative industry solution. Open-source tools have matured in their reliability and flexibility. This project 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 needed to create and maintain a compliant eCTD package will be discussed |
Project Leads | |
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Eli Miller | |
Lauren White (PHUSE Project Coordinator) |
Objectives and Deliverables | Timelines |
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Finalise White Paper | Q2 2021 |
Current Status Q22021 |
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Concluded, link to final White Paper |