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

<p><strong>Why Industry-Wide Standards Matter In Fulfilling the Intent of DSCSA</strong></p><ul><li><strong>Christiane Wirrig, PhD | </strong>Customer Success Manager, Spherity</li><li><strong>David Kessler | </strong>Co-owner and President, Legisym</li></ul><p>Discussion on the importance of standardization in order to digitalize the U.S. pharmaceutical supply chain as motivated by the Drug Supply Chain Security Act (DSCSA).</p><p><strong>Key topics</strong></p><ul><li>What is DSCSA?</li><li>What does FDA’s Stabilization Period mean?</li><li>Why do technology standards matter and how are they being implemented, i.e. interoperability through standards?</li><li>Focus on standardization, due diligence in the context of DSCSA-regulated digitally managed pharma supply chain</li><li>2023 readiness in relation to stabilization period until 2024</li><li>Inspections will keep happening</li><li>ATP is mandatory, authentication &amp; authorization</li><li>Data security</li></ul>