2023 Traceability Seminar

August 29-31, 2023 | Marriott Marquis, Washington, D.C.

2023 Traceability Seminar

August 29-31, 2023 | Marriott Marquis, Washington, D.C.

Tuesday, August 29, 2023

  • 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

Wednesday, August 30, 2023

  • 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

    • Matt Sample

      Matt Sample

      SVP, Manufacturer and Replenishment Operations

      Cencora, Inc.

  • Speakers

    • Connie Jung

      Connie Jung

      Senior Advisor for Policy

      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

  • Sponsors

  • Speakers

    • Tish E. Pahl

      Tish E. Pahl

      Principal

      Olsson Frank Weeda Terman Matz PC

    • Brian P. Waldman

      Brian P. Waldman

      Partner

      ArentFox Schiff LLP

  • Description

    This session will detail at a high level the state of readiness for DSCSA ahead of the November 27 deadline. Stakeholders will identify areas for improvements and provide an overview of the industry-guided recommendation for phased implementation submitted to FDA in May 2023.

    Sponsors

    Speakers

    • Elizabeth A. Gallenagh

      Elizabeth A. Gallenagh

      General Counsel and Senior Vice President, Supply Chain Integrity

      Healthcare Distribution Alliance

    • Gregg A. Gorniak

      Gregg A. Gorniak

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

      Cencora, Inc.

    • Tish E. Pahl

      Tish E. Pahl

      Principal

      Olsson Frank Weeda Terman Matz PC

    • Brian P. Waldman

      Brian P. Waldman

      Partner

      ArentFox Schiff LLP

  • 12:05 PM - 1:25 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 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:
    1. Barcoding and scanning issues and RFID
    2. GS1 - GLNs and Exceptions
    3. VRS
    4. Credentialing & EDDS Data Access
    5. DSCSA Phased Implementation
    6. Tracing

    Speakers

    • Robert Celeste

      Robert Celeste

      Founder

      Center for Supply Chain Studies

    • Elizabeth A. Gallenagh

      Elizabeth A. Gallenagh

      General Counsel and Senior Vice President, Supply Chain Integrity

      Healthcare Distribution Alliance

    • Gregg A. Gorniak

      Gregg A. Gorniak

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

      Cencora, Inc.

    • 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

    • Michael Rowe

      Michael Rowe

      Director, DSCSA/Serialization Services

      Two Labs Pharma Services

    • Tim  Stearns

      Tim Stearns

      Senior Director, Industry Relations

      Healthcare Distribution Alliance

    • Brian P. Waldman

      Brian P. Waldman

      Partner

      ArentFox Schiff LLP

    • Herbert Wong

      Herbert Wong

      Chief Customer Officer

      Antares Vision Group

  • Sponsors

  • Description

    Hear from state boards of pharmacy on DSCSA compliance. Speakers will also highlight some of their concerns, gaps in information and views on FDA guidance documents.

    Speakers

    • Alexandra Blasi

      Alexandra Blasi

      Executive Secretary

      Kansas Board of Pharmacy

    • Josh M. Bolin

      Josh M. Bolin

      Associate Executive Director for Government Affairs and Innovation

      National Association of Boards of Pharmacy®

    • Caroline Juran

      Caroline Juran

      Executive Director

      Virginia Board of Pharmacy

    • Jenni Wai

      Jenni Wai

      Chief Pharmacist

      The State of Ohio Board of Pharmacy

  • Description

    This year, industry leaders have participated in multiple workshops on exceptions handling as an effort to understand and systematically overcome data challenges. This session will focus on the workshop recommendations, lessons learned and updates to HDA guidance and GS1 standards.

    Sponsors

    Speakers

    • Bruce Harold

      Bruce Harold

      Director of EDI

      KeySource

    • Arthi Nagaraj

      Arthi Nagaraj

      Head of Analytics, Strategic Projects and Serialization

      Sanofi US

    • Tracy Nasarenko

      Tracy Nasarenko

      Vice President of Community Engagement, Healthcare

      GS1 US

    • Maryann Nelson

      Maryann Nelson

      Regulatory Manager

      Cardinal Health, Inc.

    • Jeff Primeau

      Jeff Primeau

      VP of Business Solutions

      Cencora - Integrated Commercialization Solutions (ICS)

    • Tim  Stearns

      Tim Stearns

      Senior Director, Industry Relations

      Healthcare Distribution Alliance

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

    Networking Reception and Table-Top Exhibits

Thursday, August 31, 2023

  • 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

    Stakeholders will discuss the challenges and accomplishments of the onboarding process to date. Speakers will address the process, lessons learned, and how the industry must activate if they plan to be prepared for DSCSA enforcement come November 27.

    Speakers

    • Riya Cao

      Riya Cao

      CEO

      LSPedia

    • William  Carney

      William Carney

      Vice President, Operations

      Genetco, Inc.

    • Blair Korman

      Blair Korman

      Sr. Director, Digital Identification & Traceability

      Johnson & Johnson Supply Chain

    • David G. Mason

      David G. Mason

      Supply Chain Compliance and Serialization Lead

      Sandoz

    • Jaidalyn Rand

      Jaidalyn Rand

      Director, Industry Relations

      Healthcare Distribution Alliance

    • Anil Suresh

      Anil Suresh

      Product Manager, DSCSA Expert

      SAP

  • Speakers

    • 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

    • Elizabeth Waldorf

      Elizabeth Waldorf

      Director, Global Traceability and Standards

      TraceLink Inc.

  • 10:35 AM - 10:45 AM

    Break

  • Speakers

    • Ilisa B.G. Bernstein

      Ilisa B.G. Bernstein

      President

      American Pharmacists Association - APHA

    • Elizabeth A. Gallenagh

      Elizabeth A. Gallenagh

      General Counsel and Senior Vice President, Supply Chain Integrity

      Healthcare Distribution Alliance

    • Jillanne Schulte Wall

      Jillanne Schulte Wall

      Senior Director, Health and Regulatory Policy

      American Society of Health-System Pharmacists (ASHP)

    • Lisa Schwartz

      Lisa Schwartz

      Senior Director, Professional Affairs

      National Community Pharmacists Association

Event Contacts