2022 Traceability Seminar

October 12-14, 2022 | Marriott Marquis, Washington, D.C.

2022 Traceability Seminar

October 12-14, 2022 | Marriott Marquis, Washington, D.C.

Wednesday, October 12, 2022

  • 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

Thursday, October 13, 2022

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

    Registration

  • Sponsors

  • Speakers

    • Perry L. Fri

      Perry L. Fri

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

      Healthcare Distribution Alliance

  • Description

    FDA has been very active over the last year, including issuing and reviewing guidance documents, hosting important DSCSA-related meetings, responding to numerous implementation queries, and issuing a very important proposed rule regarding 3PL and distributor licensure. Hear directly from the agency on recent and upcoming activities and milestones as well as their expectations for the final deadline of November 27, 2023.

    Speakers

    • Connie Jung

      Connie Jung

      Senior Advisor for Policy

      U.S. Food and Drug Administration

  • Sponsors

  • Description

    The session will highlight how state regulators are preparing for November 2023. This will include how state regulators view product tracing and how assessment of compliance will shift as full implementation of the Drug Supply Chain Security Act approaches.

    Speakers

    • Josh M. Bolin

      Josh M. Bolin

      Associate Executive Director for Government Affairs and Innovation

      National Association of Boards of Pharmacy®

  • Description

    November 27, 2023, will be here sooner than you can imagine — and the unique challenges of compliance continue. The volume of products, the many successful connections that must be established between trading partners, the intricacies of the law, and the complexities involved with preparing to respond to data and information requests are just some of the top-of-mind implementation issues. A panel of experts will discuss their implementation progress, including key impediments as well as successes, and provide recommendations to other supply chain members as they get ready for full implementation. An opportunity for questions and answers will be provided.

    Speakers

    • Anita T. Ducca

      Anita T. Ducca

      Healthcare Distribution Alliance

    • Julie Malone

      Julie Malone

      Regulatory Affairs Manager

      Value Drug Company

    • Michael J. Mazur

      Michael J. Mazur

      Director, Trade Operations

      Pfizer Inc.

    • Arthi Nagaraj

      Arthi Nagaraj

      Head of Analytics, Strategic Projects and Serialization

      Sanofi US

    • Matt Sample

      Matt Sample

      SVP, Manufacturer and Replenishment Operations

      Cencora, Inc.

  • 12:05 PM - 1:25 PM M4 - Independence Ballroom (A-H)

    Networking Luncheon and Table-Top Exhibits

  • Speakers

    • Jeffery W. Denton

      Jeffery W. Denton

      Cencora, Inc.

    • David G. Mason

      David G. Mason

      Supply Chain Compliance and Serialization Lead

      Novartis Pharmaceuticals Corporation

    • Scott A. Mooney

      Scott A. Mooney

      Vice President Distribution Operations, Traceability

      McKesson Corporation

    • Jaidalyn Rand

      Jaidalyn Rand

      Director, Industry Relations

      Healthcare Distribution Alliance

    • Elizabeth Waldorf

      Elizabeth Waldorf

      Director, Global Traceability and Standards

      TraceLink Inc.

    • Herbert Wong

      Herbert Wong

      Chief Customer Officer

      Antares Vision Group

  • Description

    Attendees will have the opportunity to discuss current operational issues associated with traceability implementation. Choose a topic of interest, rotate through tables, and convene with peers in small roundtable discussions, hosted by industry experts. Highlights from the discussions will be shared at the end of the session.

    Topics Include:

    • EPCIS & Onboarding
    • Exceptions
    • Credentialing
    • Verification
    • Dispenser Perspective
    • NDC Proposed Recommendation
    • DSCSA for State Regulators

    Sponsors

    Speakers

    • Ameer Ali

      Ameer Ali

      Sr. Director, Manufacturer Operations

      Cencora, Inc.

    • Ian Cannell

      Ian Cannell

      Business Process Consultant / DSCSA National Project Sponsor

      Kaiser Permanente

    • Robert Celeste

      Robert Celeste

      Founder

      Center for Supply Chain Studies

    • Georg Jürgens

      Georg Jürgens

      Manager Industry Solutions & OCI Co-Chair

      Spherity, Inc.

    • Mark Karhoff

      Mark Karhoff

      Principal Consultant

      Ten Count Consulting

    • 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

    • Senthil S. Rajaratnam

      Senthil S. Rajaratnam

      Senior Director, Global Serialization and UDI

      Lilly USA, LLC

    • Michael Rowe

      Michael Rowe

      Director, DSCSA/Serialization Services

      Two Labs Pharma Services

    • Elizabeth Waldorf

      Elizabeth Waldorf

      Director, Global Traceability and Standards

      TraceLink Inc.

  • 3:55 PM - 4:25 PM M4 - Independence Ballroom (A-H)

    Networking Break and Table-Top Exhibits

  • Description

    This session will provide an overview of FDA’s recent activities, emphasizing the agency’s recommendations and directives intended to guide the supply chain, state regulatory authorities and others toward DSCSA compliance. Hear important context about FDA's activities and implications for compliance.

    Speakers

    • Tish E. Pahl

      Tish E. Pahl

      Principal

      Olsson Frank Weeda Terman Matz PC

    • Brian P. Waldman

      Brian P. Waldman

      Partner

      ArentFox Schiff LLP

  • Sponsors

Friday, October 14, 2022

  • 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

    Pharmacy community experts will share their current thinking, approaches and challenges regarding the implementation of DSCSA. Topics to be addressed will include the structure of, and planning toward, a 2023 system; cost concerns; scanning and hardware upgrades across the dispensing community; communication strategies regarding packaging and bar code changes; and how dispensers report issues to FDA and suppliers.

    Speakers

    • Ronald N. Bone

      Ronald N. Bone

      HDA Consultant

      Ronald N. Bone Consulting LLC

    • Ian Cannell

      Ian Cannell

      Business Process Consultant / DSCSA National Project Sponsor

      Kaiser Permanente

    • Leon Nevers

      Leon Nevers

      Senior Director, Procurement and Business Development

      H-E-B

    • Lisa Schwartz

      Lisa Schwartz

      Senior Director, Professional Affairs

      National Community Pharmacists Association

  • Description

    Attendees will have the opportunity to discuss current operational issues associated with traceability implementation. Choose a topic of interest, rotate through tables, and convene with peers in small roundtable discussions, hosted by industry experts. Highlights from the discussions will be shared at the end of the session.

    Topics Include:

    • EPCIS & Onboarding
    • Credentialing
    • Tracing
    • Dispenser Perspective
    • GS1
    • ATP Interoperability Testing

    Sponsors

    Speakers

    • Ameer Ali

      Ameer Ali

      Sr. Director, Manufacturer Operations

      Cencora, Inc.

    • Robert Celeste

      Robert Celeste

      Founder

      Center for Supply Chain Studies

    • Georg Jürgens

      Georg Jürgens

      Manager Industry Solutions & OCI Co-Chair

      Spherity, Inc.

    • Tracy Nasarenko

      Tracy Nasarenko

      Vice President of Community Engagement, Healthcare

      GS1 US

    • Maryann Nelson

      Maryann Nelson

      Regulatory Manager

      Cardinal Health, Inc.

    • Leon Nevers

      Leon Nevers

      Senior Director, Procurement and Business Development

      H-E-B

    • Elizabeth Waldorf

      Elizabeth Waldorf

      Director, Global Traceability and Standards

      TraceLink Inc.

    • Herbert Wong

      Herbert Wong

      Chief Customer Officer

      Antares Vision Group

  • 10:50 AM - 11:00 AM

    Break

  • Speakers

    • Tracy Nasarenko

      Tracy Nasarenko

      Vice President of Community Engagement, Healthcare

      GS1 US

Event Contacts