2025 Traceability Seminar

August 4-6, 2025 | The Westin DC Downtown

2025 Traceability Seminar

August 4-6, 2025 | The Westin DC Downtown

  • 33

    Days

  • 04

    Hours

  • 17

    Minutes

Monday, August 4, 2025

  • 2:30 PM - 6:30 PM Potomac Registration Desk

    Registration

  • 5:00 PM - 6:30 PM Anacostia Ballroom

    Networking Reception and Table-Top Exhibits

Tuesday, August 5, 2025

  • 7:30 AM - 6:00 PM Potomac Registration Desk

    Registration

  • 8:30 AM - 8:45 AM Potomac Ballroom

    Opening Remarks

  • 8:45 AM - 9:45 AM Potomac Ballroom

    FDA DSCSA State of Implementation

  • 9:45 AM - 10:15 AM Anacostia Ballroom

    Networking Break and Table-Top Exhibits

  • 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

    • Ameer Ali

      Ameer Ali

      Sr. Director, Manufacturer Operations & Data Services

      Cencora, Inc.

    • Libby Dewey

      Libby Dewey

      Manager, DSCSA

      Cardinal Health, Inc.

    • Shiv Mahendran

      Associate Director, Logistics and Inventory Management

      Apotex Corp.

    • Michael J. Mazur

      Michael J. Mazur

      Director, Trade Operations

      Pfizer Inc.

    • Tim  Stearns

      Tim Stearns

      Senior Director, Industry Relations

      Healthcare Distribution Alliance

  • 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

    • Ilisa B.G. Bernstein

      Ilisa B.G. Bernstein

      President

      Bernstein Rx Solutions, LLC

    • Alexandra Blasi

      Alexandra Blasi

      Executive Secretary

      Kansas Board of Pharmacy

    • John Kirtley

      John Kirtley

      Executive Director

      Arkansas State Board of Pharmacy

    • Jenni Wai

      Jenni Wai

      Chief Pharmacist

      Ohio State Board of Pharmacy

  • 12:20 PM - 1:45 PM Anacostia Ballroom

    Networking Luncheon and Table-Top Exhibits

  • Description

    Attendees will discuss current operational issues associated with traceability implementation. Choose an expert-hosted topic of interest, rotate through, and convene with peers.

  • 3:00 PM - 3:30 PM Anacostia Ballroom

    Networking Break and Table-Top Exhibits

  • 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.

    Speakers

    • Ian Cannell

      Ian Cannell

      Business Process Consultant / DSCSA National Project Sponsor

      Kaiser Permanente

    • Justin Macy

      Justin Macy

      Director of Innovation

      National Association of Boards of Pharmacy®

    • Angela Nelson

      DSCSA

      CVS Health

    • Leon Nevers

      Leon Nevers

      Senior Director, Procurement and Business Development

      H-E-B

    • Kala Shankle

      Kala Shankle

      Vice President, Regulatory Affairs

      Healthcare Distribution Alliance

  • 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

    • Ilir Ivezaj

      Senior Product

      LSPedia

    • Mark Karhoff

      Mark Karhoff

      Principal Consultant

      Ten Count Consulting

    • Julie Malone

      Julie Malone

      Regulatory Affairs Manager

      Value Drug Company

    • Tish E. Pahl

      Tish E. Pahl

      Principal

      Olsson Frank Weeda Terman Matz PC

    • Jaidalyn Rand

      Jaidalyn Rand

      Director, Industry Relations

      Healthcare Distribution Alliance

  • 5:30 PM - 7:00 PM Anacostia Ballroom

    Networking Reception and Table-Top Exhibits

Wednesday, August 6, 2025

  • 7:30 AM - 10:30 AM Potomac Registration Desk

    Registration

  • 7:30 AM - 8:30 AM Anacostia Ballroom

    Networking Breakfast and Table-Top Exhibits

  • 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

    • Alexandra Blasi

      Alexandra Blasi

      Executive Secretary

      Kansas Board of Pharmacy

    • John Kirtley

      John Kirtley

      Executive Director

      Arkansas State Board of Pharmacy

    • Tish E. Pahl

      Tish E. Pahl

      Principal

      Olsson Frank Weeda Terman Matz PC

  • 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.

    Speakers

    • Raissa  Downs

      Raissa Downs

      Tarplin, Downs and Young, LLC

  • Speakers

    • Ameer Ali

      Ameer Ali

      Sr. Director, Manufacturer Operations & Data Services

      Cencora, Inc.

    • David G. Mason

      David G. Mason

      Director of Supply Chain Compliance

      Novartis Pharmaceuticals Corporation

  • 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.

    Speakers

    • Ilisa B.G. Bernstein

      Ilisa B.G. Bernstein

      President

      Bernstein Rx Solutions, LLC

    • David G. Mason

      David G. Mason

      Director of Supply Chain Compliance

      Novartis Pharmaceuticals Corporation