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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Description
FDA is actively finalizing Drug Supply Chain Security Act implementation, while also working to verify compliance relevant to pharmaceutical supply chain entities. This session will cover FDA updates on supply chain policy, implementation, and enforcement efforts.
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.
Sponsors
Speakers
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Ilisa B.G. Bernstein
President
Bernstein Rx Solutions, LLC
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Frank Gunson
Vice President, Regulatory Affairs & Patient Safety
McKesson Corporation
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Justin Macy
Director of Innovation
National Association of Boards of Pharmacy®
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Kala Shankle
Vice President, Regulatory Affairs
Healthcare Distribution Alliance
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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.
Speakers
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Michael J. Mazur
Director, Trade Operations
Pfizer Inc.
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Scott A. Mooney
Vice President Distribution Operations, Traceability
McKesson Corporation
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Tim Stearns
Senior Director, Industry Relations
Healthcare Distribution Alliance
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Ervin West
Supply Chain Lead DSCSA Compliance
CenterWell Pharmacy
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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 of discussion:- The Barcode Rule Change – The Non-Linear Option
- NDC-12 Rule Change (Transaction Process Impacts)
- EPCIS 1.3 Migration for DSCSA
- DSCSA 340b, Drop-ship, and Replacement Transaction Challenges
- The State of DSCSA Enforcement (483)
- Small Dispenser Exemption and What It Means for You/The End of Traceability
Speakers
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Ameer Ali
Sr. Director, Manufacturer Operations & Data Services
Cencora, Inc.
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Ilisa B.G. Bernstein
President
Bernstein Rx Solutions, LLC
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Keegan Chamberlain
Director, Quality and Regulatory Affairs
Cardinal Health, Inc.
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Abha Kundi
Counsel
ArentFox Schiff LLP
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Ullrich Mayeski
Director of Community Engagement- Healthcare
GS1 US
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Scott A. Mooney
Vice President Distribution Operations, Traceability
McKesson Corporation
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Tish E. Pahl
Principal
Olsson Frank Weeda Terman Matz PC
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Jeff Primeau
VP of Business Solutions
Cencora - Integrated Commercialization Solutions (ICS)
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Kala Shankle
Vice President, Regulatory Affairs
Healthcare Distribution Alliance
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Tim Stearns
Senior Director, Industry Relations
Healthcare Distribution Alliance
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Elizabeth Waldorf
Head of Global Traceability and Standards
TraceLink Inc.
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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 leveraging the 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.
Sponsors
Speakers
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Cathy Barbic
Associate Director, Supply Chain Projects and Compliance
Novo Nordisk Inc.
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Gregg A. Gorniak
VP - Manufacturer Operations & Data Services | Secure Supply Chain Lead
Cencora, Inc.
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David G. Mason
Director of Supply Chain Compliance
Novartis Pharmaceuticals Corporation
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Jaidalyn Rand
Director, Industry Relations
Healthcare Distribution Alliance
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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.
Sponsors
Speakers
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Ameer Ali
Sr. Director, Manufacturer Operations & Data Services
Cencora, Inc.
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Ian Cannell
Business Process Consultant / DSCSA National Project Sponsor
Kaiser Permanente
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Tim Stearns
Senior Director, Industry Relations
Healthcare Distribution Alliance
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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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Sponsors
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.
Speakers
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Sean Murphy
Senior Manager, Manufacturer Operations
Cencora, Inc.
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April Anne Sese
DSCSA Lead, Digital Identification & Traceability
Johnson & Johnson Supply Chain
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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.
Speakers
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Libby Dewey
Manager, DSCSA
Cardinal Health, Inc.
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Arthi Nagaraj
Head of Analytics, Strategic Projects and Serialization
Sanofi US
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Jaidalyn Rand
Director, Industry Relations
Healthcare Distribution Alliance
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Lisa Schwartz
Senior Director, Professional Affairs
National Community Pharmacists Association
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