Why Industry-Wide Standards Matter In Fulfilling the Intent of DSCSA
DOI:
https://doi.org/10.30953/bhty.v6.293Keywords:
Drug Supply Chain Security Act, DSCSA, FDA stabilization period, pharmaceutical supply chainAbstract
Speakers discuss the importance of standardization in order to digitalize the U.S. pharmaceutical supply chain as motivated by the Drug Supply Chain Security Act (DSCSA).
Key topics
- What is DSCSA?
- What does FDA’s Stabilization Period mean?
- Why do technology standards matter and how are they being implemented, i.e. interoperability through standards?
- Focus on standardization, due diligence in the context of DSCSA-regulated digitally managed pharma supply chain
- 2023 readiness in relation to stabilization period until 2024
- Inspections will keep happening
- ATP is mandatory, authentication & authorization
- Data security
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Published
2023-12-03
How to Cite
Wirrig, PhD, C. ., & Kessler, D. . (2023). Why Industry-Wide Standards Matter In Fulfilling the Intent of DSCSA. Blockchain in Healthcare Today, 6(2). https://doi.org/10.30953/bhty.v6.293
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Podcast
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Copyright (c) 2023 Christiane Wirrig, PhD, David Kessler
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors retain copyright of their work, with first publication rights granted to Blockchain in Healthcare Today (BHTY). Read the full Copyright Statement.
