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Mar 9, 2023
How centralized ATP repositories complicate DSCSA-regulated product verifications
Lately, I have come across a few misconceptions around DSCSA-related Authorized Trading Partner (ATP) checks that I’d like to address here. If you are affected by the impending full-blown DSCSA enforcement by November 2023 and have already looked into compliance solutions,...
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caro
Jan 25, 2023
Hat-trick in U.S. pharma innovation
The U.S. Drug Supply Chain Security Act (DSCSA) aims to secure patient safety by increasing supply chain integrity. Hence, all pharmaceutical supply chain actors should ideally only interact with those that meet the DSCSA Authorized Trading Partner (ATP) status when they...
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vera
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Pharma
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Oct 11, 2024
FDA exemption for connected trading partners
DSCSA news are coming in thick and fast these days. Following their exemption for small dispensers in July 2024 and recurring reminders of the waivers, exceptions and exemptions (WEE) request process, FDA has just issued a new large-scale exemption to connected trading partners...
Read full storyPharma
caro
Oct 3, 2024
The 2x2 Matrix: DPPs and the Paradigm Shift Toward Dynamic, AI-Driven Supply Chains
This article explores the current trends and future potential of Digital Product Passports (DPPs), using a 2x2 Matrix to categorize them into four DPP types: Data Vaults, Smart Compliance, Insight Engine, and Cyber-physical...
Read full storyBattery & automotive
vera
Sep 4, 2024
Amsterdam to Washington: On a DSCSA mission
It’s a sunny Sunday afternoon. I board the plane in Amsterdam. Four documentaries and a couple of meal breaks later, and I find myself in Washington DC...
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caro
Aug 26, 2024
Unlocking the Full Potential of DPPs in Textile, Footwear, and Fashion Industry
The European Union’s drive for sustainability through regulations like the Ecodesign for Sustainable Products Regulation (ESPR) has made Digital Product Passports (DPPs) an essential compliance tool for companies...
Read full storyBattery & automotive
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