Why Industry-Wide Standards Matter In Fulfilling the Intent of DSCSA

Authors

  • Christiane Wirrig, PhD Customer Success Manager, Spherity
  • David Kessler Co-owner and President, Legisym

DOI:

https://doi.org/10.30953/bhty.v6.293

Keywords:

Drug Supply Chain Security Act, DSCSA, FDA stabilization period, pharmaceutical supply chain

Abstract

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

Issue

Vol. 6 No. 2 (2023): Blockchain in Healthcare Today

Section

Podcast

License

Copyright (c) 2023 Christiane Wirrig, PhD, David Kessler

Creative Commons License

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.