2026 Traceability Seminar
August 31 - September 2, 2026 | Marriott Marquis Washington, DC
Monday, August 31, 2026
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2:30 PM - 6:30 PM Independence Foyer
Registration
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5:00 PM - 6:30 PM Independence Ballroom
Networking Reception and Table-Top Exhibits
Tuesday, September 1, 2026
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7:30 AM - 6:00 PM Independence Foyer
Registration
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7:30 AM - 8:30 AM Independence Ballroom
Networking Breakfast and Table-Top Exhibits
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8:30 AM - 8:45 AM Liberty Ballroom
Opening Remarks
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Speakers
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Aaron Weisbuch
Senior Regulatory Advisor, CDER
U.S. Food and Drug Administration
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9:45 AM - 10:15 AM Independence Ballroom
Networking Break and Table-Top Exhibits
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Description
As FDA continues to advance national licensure standards for wholesale distributors and 3PLs, industry stakeholders are beginning to assess the potential operational, quality and compliance implications. This panel will explore key considerations for implementation, preparedness strategies and the evolving role of state boards of pharmacy in a standardized licensure framework.
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Description
This session will explore challenges with business-to-business and back-office ERP-to-EPCIS integration, GLN format issues, transitioning from GLN to sGLN, and optimizing 340B transactions.
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12:20 PM - 1:45 PM Independence Ballroom
Networking Luncheon and Table-Top Exhibits
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Description
Attendees will have the opportunity to discuss current operational issues associated with traceability implementation. Choose a topic of interest, rotate through and convene with peers, hosted by industry experts.Topics:• Non-linear Barcode Rule Change
• NDC-12 Rule Change (Transaction Process Effects)
• EPCIS 1.3 Migration for DSCSA
• Importation Notice in the EDI ASN
• DSCSA 340B, DropShip and Replacement Transaction Challenges -
3:00 PM - 3:30 PM Independence Ballroom
Networking Break and Table-Top Exhibits
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Description
This session will explore how the pharmaceutical supply chain is moving beyond basic DSCSA compliance and leveragingthe law’s requirements to drive operational improvements, efficiency and innovation. Attendees will learn how industry stakeholders are using emerging technologies— such as artificial intelligence and enhanced RFID capabilities — to strengthen supply chain visibility, streamline transactions and improve business processes. The discussion will highlight how trading partners and industry leaders are transforming compliance investments into strategic opportunities that create value across the supply chain.
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Description
This session will cover what you shouldbe doing to prepare for NDC-12 related to EDI, back-office systems, DSCSA and packaging-line systems, and beyond.
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5:30 PM - 7:00 PM Independence Ballroom
Networking Reception and Table-Top Exhibits
Wednesday, September 2, 2026
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7:30 AM - 10:30 AM Independence Foyer
Registration
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7:30 AM - 8:30 AM Independence Ballroom
Networking Breakfast and Table-Top Exhibits
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Speakers
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Leyla Rahjou-Esfandiary
Branch Chief, Center for Drug Evaluation and Research
U.S. Food and Drug Administration
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Kelly Wilson
Branch Chief, Prescription Drugs Branch, Office of Unapproved Drugs and Labeling Compliance
U.S. Food and Drug Administration
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9:30 AM - 9:45 AM
Movement Break
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Description
When product labeling and business-to-business transaction changes are implemented, issues are inevitable. Hear from panelists on what to watch out for and how to deal with challenges as NDC-12 changes are deployed.
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Description
With systems in place prior to the rule effective March 7, 2033, hear from industry experts how industry might operationally work through the three-year transition to NDC-12 as specified in the final rule.