2024 Traceability Seminar

August 26-28, 2024 | Marriott Marquis, Washington, D.C.

2024 Traceability Seminar

August 26-28, 2024 | Marriott Marquis, Washington, D.C.

Monday, August 26, 2024

  • 2:30 PM - 6:30 PM M4 - Independence Ballroom Foyer

    Registration

  • 5:00 PM - 6:30 PM M4 - Independence Ballroom (A-H)

    Networking Reception and Table-Top Exhibits

Tuesday, August 27, 2024

  • 7:30 AM - 6:00 PM M4 - Independence Ballroom Foyer

    Registration

  • 7:30 AM - 8:30 AM M4 - Independence Ballroom (A-H)

    Networking Breakfast and Table-Top Exhibits

  • Speakers

    • Perry L. Fri

      Perry L. Fri

      Executive Vice President, Industry Relations & Member Services and COO, HDA Research Foundation

      Healthcare Distribution Alliance

  • Description

    FDA continues to be active on DSCSA implementation efforts and stakeholder engagement. Hear directly from the agency on recent and upcoming milestones as well as expectations for the end of the stabilization period on November 27, 2024.

    Sponsors

    Speakers

    • Abha Kundi

      Abha Kundi

      Team Lead in the Office of Drug Security, Integrity and Response

      Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

    • Leigh Verbois

      Leigh Verbois

      Director of the Office of Drug Security, Integrity and Response

      Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

  • 9:45 AM - 10:15 AM M4 - Independence Ballroom (A-H)

    Networking Break and Table-Top Exhibits

  • Description

    This year, industry leaders have participated in multiple workshops on exceptions handling to understand and overcome data challenges. This session will focus on the workshop recommendations, lessons learned and updates to HDA guidance and GS1 standards. Speakers will review how receiving processes have worked after DSCSA processes coming online.

    Sponsors

    Speakers

    • Craig Little

      Craig Little

      Senior Systems Developer

      Value Drug Company

    • Ullrich Mayeski

      Ullrich Mayeski

      Director of Community Engagement

      GS1 US

    • Scott A. Mooney

      Scott A. Mooney

      Vice President Distribution Operations, Traceability

      McKesson Corporation

    • Tim  Stearns

      Tim Stearns

      Senior Director, Industry Relations

      Healthcare Distribution Alliance

  • Description

    This session will address what HDA distributors are experiencing in the supply chain and efforts to adapt to the end of the stabilization period in November.  Speakers will review the Waiver, Exception or Exemption (WEE) request process, the impacts of FDA-granted WEEs on the supply chain, and the small dispenser exemption.  The speakers will leave time for a robust Q& A session.

    Speakers

    • Elizabeth A. Gallenagh

      Elizabeth A. Gallenagh

      General Counsel and Senior Vice President, Supply Chain Integrity

      Healthcare Distribution Alliance

    • Tish E. Pahl

      Tish E. Pahl

      Principal

      Olsson Frank Weeda Terman Matz PC

    • Brian P. Waldman

      Brian P. Waldman

      Partner

      ArentFox Schiff LLP

  • 12:20 PM - 1:45 PM M4 - Independence Ballroom (A-H)

    Networking Luncheon and Table-Top Exhibits

  • 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.

    1. Exceptions Handling
    2. Managing Waivers-Exceptions-Exemptions
    3. Saleable Returns Verifications
    4. VRS System
    5. GS1 – Data Hub
    6. NDC Rule
    7. Dispenser Perspectives

    Speakers

    • Marc Blekkink

      Marc Blekkink

      Managing Director Movilitas.Cloud

      Movilitas.Cloud

    • Riya Cao

      Riya Cao

      CEO

      LSPedia

    • Scott T. Hatakeyama

      Scott T. Hatakeyama

      Director, Inventory Management and Optimization

      Kaiser Permanente

    • Abha Kundi

      Abha Kundi

      Team Lead in the Office of Drug Security, Integrity and Response

      Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

    • Ullrich Mayeski

      Ullrich Mayeski

      Director of Community Engagement

      GS1 US

    • Scott A. Mooney

      Scott A. Mooney

      Vice President Distribution Operations, Traceability

      McKesson Corporation

    • Tracy Nasarenko

      Tracy Nasarenko

      Vice President of Community Engagement, Healthcare

      GS1 US

    • Maryann Nelson

      Maryann Nelson

      Regulatory Manager

      Cardinal Health, Inc.

    • Tish E. Pahl

      Tish E. Pahl

      Principal

      Olsson Frank Weeda Terman Matz PC

    • Jeff Primeau

      Jeff Primeau

      VP of Business Solutions

      Cencora - Integrated Commercialization Solutions (ICS)

    • Tim  Stearns

      Tim Stearns

      Senior Director, Industry Relations

      Healthcare Distribution Alliance

  • Sponsors

  • Description

    Learn how best to prepare for and go through an FDA inspection.

    Speakers

    • Jeb Hunter

      Jeb Hunter

      Senior Regulatory Consultant

      EAS Consulting Group

  • Description

    The amount and quality of serialized data will be the driving factors for avoiding exceptions. Informed by data from HDA’s Data Exchange Benchmarking Survey, this panel will discuss how data is moving downstream, what feedback trading partners are providing and how the industry is working collaboratively to deliver product with DSCSA data by November 27.

    Speakers

    • Cathy Barbic

      Cathy Barbic

      Associate Director, Supply Chain Projects and Compliance

      Novo Nordisk Inc.

    • Ashley Y. DeFlice

      Ashley Y. DeFlice

      Senior Regulatory Affairs Specialist

      Henry Schein, Inc.

    • Libby Dewey

      Libby Dewey

      Manager, DSCSA

      Cardinal Health, Inc.

    • Gregg A. Gorniak

      Gregg A. Gorniak

      VP - Manufacturer Operations & Data Services | Secure Supply Chain Lead

      Cencora, Inc.

    • Jaidalyn Rand

      Jaidalyn Rand

      Director, Industry Relations

      Healthcare Distribution Alliance

  • 5:30 PM - 7:00 PM M4 - Independence Ballroom (A-H)

    Networking Reception and Table-Top Exhibits

Wednesday, August 28, 2024

  • 7:30 AM - 10:30 AM M4 - Independence Ballroom Foyer

    Registration

  • 7:30 AM - 8:30 AM M4 - Independence Ballroom (A-H)

    Networking Breakfast and Table-Top Exhibits

  • 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.

    1. Exceptions Handling
    2. Managing Waivers-Exceptions-Exemptions
    3. Saleable Returns Verifications
    4. VRS System
    5. GS1 – Data Hub
    6. NDC Rule
    7. Dispenser Perspectives

    Speakers

    • Marc Blekkink

      Marc Blekkink

      Managing Director Movilitas.Cloud

      Movilitas.Cloud

    • Riya Cao

      Riya Cao

      CEO

      LSPedia

    • Scott T. Hatakeyama

      Scott T. Hatakeyama

      Director, Inventory Management and Optimization

      Kaiser Permanente

    • Abha Kundi

      Abha Kundi

      Team Lead in the Office of Drug Security, Integrity and Response

      Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

    • Ullrich Mayeski

      Ullrich Mayeski

      Director of Community Engagement

      GS1 US

    • Scott A. Mooney

      Scott A. Mooney

      Vice President Distribution Operations, Traceability

      McKesson Corporation

    • Tracy Nasarenko

      Tracy Nasarenko

      Vice President of Community Engagement, Healthcare

      GS1 US

    • Maryann Nelson

      Maryann Nelson

      Regulatory Manager

      Cardinal Health, Inc.

    • Tish E. Pahl

      Tish E. Pahl

      Principal

      Olsson Frank Weeda Terman Matz PC

    • Jeff Primeau

      Jeff Primeau

      VP of Business Solutions

      Cencora - Integrated Commercialization Solutions (ICS)

    • Tim  Stearns

      Tim Stearns

      Senior Director, Industry Relations

      Healthcare Distribution Alliance

  • 9:45 AM - 9:55 AM

    Movement Break

  • Description

    This session will cover the VRS Provider Network including plans for the network’s new governance structure. Learn about the feedback mechanism driving the recent updates and enhancement of the VRS solution.

    Speakers

    • Justin Macy

      Justin Macy

      Director of Innovation

      National Association of Boards of Pharmacy®

    • David G. Mason

      David G. Mason

      Supply Chain Compliance and Serialization Lead

      Novartis Pharmaceuticals Corporation

    • Michael J. Mazur

      Michael J. Mazur

      Director, Trade Operations

      Pfizer Inc.

    • Jaidalyn Rand

      Jaidalyn Rand

      Director, Industry Relations

      Healthcare Distribution Alliance

    • Herbert Wong

      Herbert Wong

      Chief Customer Officer

      Antares Vision Group

  • Description

    Hear from national attorneys whose practice includes counseling trading partners on legal and compliance DSCSA matters. Counsel will provide insights on novel questions they have faced in their practice, including handling 340B products, ensuring traceability with unique trading partners, and managing standard operating procedures. Panelists will also discuss best practices for compliance teams to consider as the end of the stabilization period nears.

    Speakers

    • Ilisa B.G. Bernstein

      Ilisa B.G. Bernstein

      President

      Bernstein Rx Solutions, LLC

    • Jennell Bilek

      Jennell Bilek

      Equity Partner

      Carlson Caspers IP Litigation & Counseling

    • Kala Shankle

      Kala Shankle

      Vice President, Regulatory Affairs

      Healthcare Distribution Alliance

    • Chris Smith

      Chris Smith

      Senior Counsel

      Epstein Becker & Green, P.C.

    • Theodore  Sullivan

      Theodore Sullivan

      Partner

      Quarles & Brady LLP