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UID:50927-1637053200-1637078400@globalbiodefense.com
SUMMARY:Enhanced Drug Distribution Security at the Package Level
DESCRIPTION:The FDA will hold a virtual public meeting on November 16\, 2021\, on enhanced drug distribution security at the package level. \nThe purpose of this public meeting is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to provide input to FDA on the implementation of the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) that go into effect in 2023. \nFDA requests that stakeholders prepare comments responding to the following questions for one or more of the topics listed below: \n\nHow is implementation of the 2023 enhanced system requirements progressing for your organization?\nWhat challenges is your organization facing?\nAre the proposed recommendations in FDA’s guidance on enhanced drug distribution security at the package level helpful to achieve compliance with 2023 enhanced system requirements? If not\, what additional information would be useful?\nAre there areas in which FDA could provide more clarity?\n\nTopics\n\nEnhanced Drug Distribution Security\n\nSystem Attributes\nAggregation\, Inference\, and Physical Security Features\n\n\nSystem Structure\n\nData Architecture\nAdoption of Data and System Security\nProtecting Confidential Commercial Information and Trade Secrets\nSystem Access and Data Retrieval\n\n\nEnhanced Product Tracing\n\nSerialized Transaction Information and Data Exchange (Incorporation of the Product Identifier into Product Tracing Information)\nResponsibilities of the Selling and Buying Trading Partners with regard to the Product Tracing Information\nHandling Aggregation Errors and Other Discrepancies\n\n\nGathering of Relevant Product Tracing Information\nEnhanced Verification\n\nVerification of Distributed Product\nVerification of Saleable Return Product\nAlerts for Illegitimate Product\n\n\nTrading Partner Readiness\n\nYour organization’s overall readiness for implementation\nComponents that your organization is furthest along in developing\, including the components being prioritized and the components that are easier or more challenging to implement\n\n\n\nAdditional Information\n\nEnhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Draft Guidance for Industry\nFDA Webinar on October 5\, 2021: Enhanced Drug Distribution Security in 2023 Under the DSCSA
URL:https://globalbiodefense.com/event/enhanced-drug-distribution-security-at-the-package-level/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
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