2025 Traceability Seminar
August 4-6, 2025 | The Westin DC Downtown
Monday, August 4, 2025
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2:30 PM - 6:30 PM
Registration
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5:00 PM - 6:30 PM
Networking Reception and Table-Top Exhibits
Tuesday, August 5, 2025
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7:30 AM - 6:00 PM
Registration
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8:30 AM - 8:45 AM
Opening Remarks
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8:45 AM - 9:45 AM
FDA DSCSA State of Implementation
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9:45 AM - 10:15 AM
Networking Break and Table-Top Exhibits
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Description
FDA final guidance stipulates that the selling trading partner should reconcile the transaction information against the product it sells to a purchasing trading partner. Hear from industry experts about best practices for ensuring timely, complete, correct and accurate EPCIS TI.
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Description
Regulators representing several state Boards of Pharmacy will voice their perspectives on DSCSA enforcement as the law goes into effect throughout the year. Regulators will address the challenges with enforcement, consider best practices for industry, and highlight the importance of communication and partnership with regulators and industry throughout 2025 and beyond.
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12:20 PM - 1:45 PM
Networking Luncheon and Table-Top Exhibits
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Description
Attendees will discuss current operational issues associated with traceability implementation. Choose an expert-hosted topic of interest, rotate through, and convene with peers.
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3:00 PM - 3:30 PM
Networking Break and Table-Top Exhibits
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Description
The pharmacy community is navigating the final stages of DSCSA implementation as the November 27 dispenser compliance deadline approaches. This panel will feature diverse perspectives from the dispensing sector —
including retail, health-system, and independent pharmacies — as they share current readiness levels, remaining challenges and anticipated operational changes.
Panelists will discuss issues such as interoperability with suppliers, scanning and hardware upgrades, label and barcode changes, and cost pressures unique to the dispensing community. The session will also explore how dispensers are approaching verification, trace requests, and suspect product reporting, as well as their expectations for support and coordination from upstream partners.
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Description
This session will take a deeper look into the VRS Provider Network’s process of finetuning the VRS solution through governance, transparent reporting and stakeholder feedback. The panel will cover critical findings, work group collaboration, lessons learned, stakeholder input, and key activities driving industry adoption.
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5:30 PM - 7:00 PM
Networking Reception and Table-Top Exhibits
Wednesday, August 6, 2025
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7:30 AM - 10:30 AM
Registration
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7:30 AM - 8:30 AM
Networking Breakfast and Table-Top Exhibits
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8:30 AM - 9:30 AM
GLP-1 Investigations: What It Means for the Supply Chain
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9:30 AM - 9:45 AM
Movement Break
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Description
With new leadership at HHS and FDA, healthcare supply chain stakeholders are watching closely for signals about future priorities, enforcement shifts and structural changes. This session will assess the evolving landscape and what it may mean for FDA oversight, DSCSA implementation, supply chain resilience initiatives and broader pharmaceutical policies.
Hear how agency staffing changes, regulatory reviews and White House directives may shape the near-term policy agenda — and what distributors and supply chain partners should be tracking to stay ahead of emerging expectations. -
Description
As DSCSA implementation stabilizes, certain FDA inspections are beginning to place a sharper focus on traceability requirements — particularly the systems, records, and practices supporting serialized transaction data exchange. This session will evaluate how traceability expectations are shaping inspection protocols and what wholesale distributors
can expect during facility audits.
Experts will walk through real-world inspection triggers; examples of common deficiencies; and the evolving role of EPCIS data, WEER reporting and interoperability in compliance reviews.