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 Potomac Registration Desk
Registration
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5:00 PM - 6:30 PM Anacostia Ballroom
Networking Reception and Table-Top Exhibits
Tuesday, August 5, 2025
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7:30 AM - 6:00 PM Potomac Registration Desk
Registration
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8:30 AM - 8:45 AM Potomac Ballroom
Opening Remarks
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8:45 AM - 9:45 AM Potomac Ballroom
FDA DSCSA State of Implementation
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9:45 AM - 10:15 AM Anacostia Ballroom
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.
Speakers
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Ameer Ali
Sr. Director, Manufacturer Operations & Data Services
Cencora, Inc.
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Libby Dewey
Manager, DSCSA
Cardinal Health, Inc.
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Shiv Mahendran
Associate Director, Logistics and Inventory Management
Apotex Corp.
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Michael J. Mazur
Director, Trade Operations
Pfizer Inc.
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Tim Stearns
Senior Director, Industry Relations
Healthcare Distribution Alliance
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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.
Speakers
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Ilisa B.G. Bernstein
President
Bernstein Rx Solutions, LLC
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Alexandra Blasi
Executive Secretary
Kansas Board of Pharmacy
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John Kirtley
Executive Director
Arkansas State Board of Pharmacy
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Jenni Wai
Chief Pharmacist
Ohio State Board of Pharmacy
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12:20 PM - 1:45 PM Anacostia Ballroom
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 Anacostia Ballroom
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.
Speakers
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Ian Cannell
Business Process Consultant / DSCSA National Project Sponsor
Kaiser Permanente
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Justin Macy
Director of Innovation
National Association of Boards of Pharmacy®
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Angela Nelson
DSCSA
CVS Health
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Leon Nevers
Senior Director, Procurement and Business Development
H-E-B
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Kala Shankle
Vice President, Regulatory Affairs
Healthcare Distribution Alliance
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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.
Speakers
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Ilir Ivezaj
Senior Product
LSPedia
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Mark Karhoff
Principal Consultant
Ten Count Consulting
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Julie Malone
Regulatory Affairs Manager
Value Drug Company
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Tish E. Pahl
Principal
Olsson Frank Weeda Terman Matz PC
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Jaidalyn Rand
Director, Industry Relations
Healthcare Distribution Alliance
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5:30 PM - 7:00 PM Anacostia Ballroom
Networking Reception and Table-Top Exhibits
Wednesday, August 6, 2025
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7:30 AM - 10:30 AM Potomac Registration Desk
Registration
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7:30 AM - 8:30 AM Anacostia Ballroom
Networking Breakfast and Table-Top Exhibits
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Description
This session will cover a multistate investigation of illegitimate GLP-1s quarantined by an Arkansas pharmacy. The panel will walk through how following DSCSA protocols led to the product quarantine and the role verification tools played to promptly remove unsafe drugs from the supply chain.
Speakers
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Alexandra Blasi
Executive Secretary
Kansas Board of Pharmacy
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John Kirtley
Executive Director
Arkansas State Board of Pharmacy
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Tish E. Pahl
Principal
Olsson Frank Weeda Terman Matz PC
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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.Speakers
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Raissa Downs
Tarplin, Downs and Young, LLC
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Speakers
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Ameer Ali
Sr. Director, Manufacturer Operations & Data Services
Cencora, Inc.
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David G. Mason
Director of Supply Chain Compliance
Novartis Pharmaceuticals Corporation
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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.
Speakers
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Ilisa B.G. Bernstein
President
Bernstein Rx Solutions, LLC
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David G. Mason
Director of Supply Chain Compliance
Novartis Pharmaceuticals Corporation
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