2023 Traceability Seminar
August 29-31, 2023 | Marriott Marquis, Washington, D.C.
Tuesday, August 29, 2023
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2:30 PM - 6:30 PM M4 - Independence Ballroom Foyer
Registration
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5:00 PM - 6:30 PM M4 - Independence Ballroom (A-H)
Networking Reception and Table-Top Exhibits
Wednesday, August 30, 2023
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7:30 AM - 6:00 PM M4 - Independence Ballroom Foyer
Registration
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7:30 AM - 8:30 AM M4 - Independence Ballroom (A-H)
Networking Breakfast and Table-Top Exhibits
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Speakers
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Perry L. Fri
Executive Vice President, Industry Relations & Member Services and COO, HDA Research Foundation
Healthcare Distribution Alliance
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Matt Sample
SVP, Manufacturer and Replenishment Operations
Cencora, Inc.
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Speakers
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Connie Jung
Senior Advisor for Policy
U.S. Food and Drug Administration
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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
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Sponsors
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Speakers
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Tish E. Pahl
Principal
Olsson Frank Weeda Terman Matz PC
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Brian P. Waldman
Partner
ArentFox Schiff LLP
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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
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Elizabeth A. Gallenagh
General Counsel and Senior Vice President, Supply Chain Integrity
Healthcare Distribution Alliance
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Gregg A. Gorniak
VP - Manufacturer Operations & Data Services | Secure Supply Chain Lead
Cencora, Inc.
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Tish E. Pahl
Principal
Olsson Frank Weeda Terman Matz PC
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Brian P. Waldman
Partner
ArentFox Schiff LLP
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12:05 PM - 1:25 PM M4 - Independence Ballroom (A-H)
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 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:- Barcoding and scanning issues and RFID
- GS1 - GLNs and Exceptions
- VRS
- Credentialing & EDDS Data Access
- DSCSA Phased Implementation
- Tracing
Speakers
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Robert Celeste
Founder
Center for Supply Chain Studies
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Elizabeth A. Gallenagh
General Counsel and Senior Vice President, Supply Chain Integrity
Healthcare Distribution Alliance
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Gregg A. Gorniak
VP - Manufacturer Operations & Data Services | Secure Supply Chain Lead
Cencora, Inc.
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Tracy Nasarenko
Vice President of Community Engagement, Healthcare
GS1 US
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Maryann Nelson
Regulatory Manager
Cardinal Health, Inc.
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Tish E. Pahl
Principal
Olsson Frank Weeda Terman Matz PC
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Michael Rowe
Director, DSCSA/Serialization Services
Two Labs Pharma Services
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Tim Stearns
Senior Director, Industry Relations
Healthcare Distribution Alliance
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Brian P. Waldman
Partner
ArentFox Schiff LLP
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Herbert Wong
Chief Customer Officer
Antares Vision Group
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Sponsors
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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
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Alexandra Blasi
Executive Secretary
Kansas Board of Pharmacy
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Josh M. Bolin
Associate Executive Director for Government Affairs and Innovation
National Association of Boards of Pharmacy®
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Caroline Juran
Executive Director
Virginia Board of Pharmacy
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Jenni Wai
Chief Pharmacist
The State of Ohio Board of Pharmacy
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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
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Bruce Harold
Director of EDI
KeySource
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Arthi Nagaraj
Head of Analytics, Strategic Projects and Serialization
Sanofi US
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Tracy Nasarenko
Vice President of Community Engagement, Healthcare
GS1 US
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Maryann Nelson
Regulatory Manager
Cardinal Health, Inc.
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Jeff Primeau
VP of Business Solutions
Cencora - Integrated Commercialization Solutions (ICS)
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Tim Stearns
Senior Director, Industry Relations
Healthcare Distribution Alliance
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5:30 PM - 7:00 PM M4 - Independence Ballroom (A-H)
Networking Reception and Table-Top Exhibits
Thursday, August 31, 2023
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7:30 AM - 10:30 AM M4 - Independence Ballroom Foyer
Registration
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7:30 AM - 8:30 AM M4 - Independence Ballroom (A-H)
Networking Breakfast and Table-Top Exhibits
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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
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Riya Cao
CEO
LSPedia
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William Carney
Vice President, Operations
Genetco, Inc.
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Blair Korman
Sr. Director, Digital Identification & Traceability
Johnson & Johnson Supply Chain
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David G. Mason
Supply Chain Compliance and Serialization Lead
Sandoz
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Jaidalyn Rand
Director, Industry Relations
Healthcare Distribution Alliance
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Anil Suresh
Product Manager, DSCSA Expert
SAP
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Speakers
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Scott A. Mooney
Vice President Distribution Operations, Traceability
McKesson Corporation
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Tracy Nasarenko
Vice President of Community Engagement, Healthcare
GS1 US
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Elizabeth Waldorf
Director, Global Traceability and Standards
TraceLink Inc.
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10:35 AM - 10:45 AM
Break
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Speakers
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Ilisa B.G. Bernstein
President
American Pharmacists Association - APHA
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Elizabeth A. Gallenagh
General Counsel and Senior Vice President, Supply Chain Integrity
Healthcare Distribution Alliance
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Jillanne Schulte Wall
Senior Director, Health and Regulatory Policy
American Society of Health-System Pharmacists (ASHP)
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Lisa Schwartz
Senior Director, Professional Affairs
National Community Pharmacists Association
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Event Contacts
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Registration and Hotel Information
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Sponsorship Opportunities
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Exhibit Opportunities
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Membership
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Conference Schedule, Speaker Information, and Education Content