2022 Traceability Seminar
October 12-14, 2022 | Marriott Marquis, Washington, D.C.
Wednesday, October 12, 2022
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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
Thursday, October 13, 2022
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7:30 AM - 6:00 PM M4 - Independence Ballroom Foyer
Registration
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Sponsors
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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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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
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Connie Jung
Senior Advisor for Policy
U.S. Food and Drug Administration
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Sponsors
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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
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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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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
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Anita T. Ducca
Healthcare Distribution Alliance
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Julie Malone
Regulatory Affairs Manager
Value Drug Company
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Michael J. Mazur
Director, Trade Operations
Pfizer Inc.
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Arthi Nagaraj
Head of Analytics, Strategic Projects and Serialization
Sanofi US
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Matt Sample
SVP, Manufacturer and Replenishment Operations
Cencora, Inc.
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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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Speakers
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Jeffery W. Denton
Cencora, Inc.
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David G. Mason
Supply Chain Compliance and Serialization Lead
Novartis Pharmaceuticals Corporation
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Scott A. Mooney
Vice President Distribution Operations, Traceability
McKesson Corporation
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Jaidalyn Rand
Director, Industry Relations
Healthcare Distribution Alliance
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Elizabeth Waldorf
Director, Global Traceability and Standards
TraceLink Inc.
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Herbert Wong
Chief Customer Officer
Antares Vision Group
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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:
- EPCIS & Onboarding
- Exceptions
- Credentialing
- Verification
- Dispenser Perspective
- NDC Proposed Recommendation
- DSCSA for State Regulators
Sponsors
Speakers
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Ameer Ali
Sr. Director, Manufacturer Operations
Cencora, Inc.
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Ian Cannell
Business Process Consultant / DSCSA National Project Sponsor
Kaiser Permanente
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Robert Celeste
Founder
Center for Supply Chain Studies
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Georg Jürgens
Manager Industry Solutions & OCI Co-Chair
Spherity, Inc.
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Mark Karhoff
Principal Consultant
Ten Count Consulting
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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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Senthil S. Rajaratnam
Senior Director, Global Serialization and UDI
Lilly USA, LLC
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Michael Rowe
Director, DSCSA/Serialization Services
Two Labs Pharma Services
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Elizabeth Waldorf
Director, Global Traceability and Standards
TraceLink Inc.
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3:55 PM - 4:25 PM M4 - Independence Ballroom (A-H)
Networking Break and Table-Top Exhibits
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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
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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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Sponsors
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Friday, October 14, 2022
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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
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
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Ronald N. Bone
HDA Consultant
Ronald N. Bone Consulting LLC
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Ian Cannell
Business Process Consultant / DSCSA National Project Sponsor
Kaiser Permanente
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Leon Nevers
Senior Director, Procurement and Business Development
H-E-B
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Lisa Schwartz
Senior Director, Professional Affairs
National Community Pharmacists Association
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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:
- EPCIS & Onboarding
- Credentialing
- Tracing
- Dispenser Perspective
- GS1
- ATP Interoperability Testing
Sponsors
Speakers
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Ameer Ali
Sr. Director, Manufacturer Operations
Cencora, Inc.
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Robert Celeste
Founder
Center for Supply Chain Studies
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Georg Jürgens
Manager Industry Solutions & OCI Co-Chair
Spherity, 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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Leon Nevers
Senior Director, Procurement and Business Development
H-E-B
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Elizabeth Waldorf
Director, Global Traceability and Standards
TraceLink Inc.
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Herbert Wong
Chief Customer Officer
Antares Vision Group
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10:50 AM - 11:00 AM
Break
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Speakers
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Tracy Nasarenko
Vice President of Community Engagement, Healthcare
GS1 US
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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