2024 Traceability Seminar
August 26-28, 2024 | Marriott Marquis, Washington, D.C.
Monday, August 26, 2024
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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
Tuesday, August 27, 2024
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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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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
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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
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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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9:45 AM - 10:15 AM M4 - Independence Ballroom (A-H)
Networking Break and Table-Top Exhibits
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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
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Craig Little
Senior Systems Developer
Value Drug Company
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Ullrich Mayeski
Director of Community Engagement
GS1 US
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Scott A. Mooney
Vice President Distribution Operations, Traceability
McKesson Corporation
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Tim Stearns
Senior Director, Industry Relations
Healthcare Distribution Alliance
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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
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Elizabeth A. Gallenagh
General Counsel and Senior Vice President, Supply Chain Integrity
Healthcare Distribution Alliance
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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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12:20 PM - 1:45 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 and convene with peers, hosted by industry experts.
- Exceptions Handling
- Managing Waivers-Exceptions-Exemptions
- FDA’s DSCSA Portal
- VRS System
- GS1 – Data Hub
- NDC Rule
- Dispenser Perspectives
Speakers
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Marc Blekkink
Managing Director Movilitas.Cloud
Movilitas.Cloud
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Riya Cao
CEO
LSPedia
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Bruce Harold
Director of EDI
KeySource
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Scott T. Hatakeyama
Director, Inventory Management and Optimization
Kaiser Permanente
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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
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Ullrich Mayeski
Director of Community Engagement
GS1 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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Tish E. Pahl
Principal
Olsson Frank Weeda Terman Matz PC
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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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Sponsors
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Description
Learn how best to prepare for and go through an FDA inspection.
Speakers
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Jeb Hunter
Senior Regulatory Consultant
EAS Consulting Group
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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
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Cathy Barbic
Associate Director, Supply Chain Projects and Compliance
Novo Nordisk Inc.
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Ashley Y. DeFlice
Senior Regulatory Affairs Specialist
Henry Schein, Inc.
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Libby Dewey
Manager, DSCSA
Cardinal Health, Inc.
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Gregg A. Gorniak
VP - Manufacturer Operations & Data Services | Secure Supply Chain Lead
Cencora, Inc.
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Jaidalyn Rand
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
Wednesday, August 28, 2024
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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
-
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.
- Exceptions Handling
- Managing Waivers-Exceptions-Exemptions
- FDA’s DSCSA Portal
- VRS System
- GS1 – Data Hub
- NDC Rule
- Dispenser Perspectives
Speakers
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Marc Blekkink
Managing Director Movilitas.Cloud
Movilitas.Cloud
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Riya Cao
CEO
LSPedia
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Bruce Harold
Director of EDI
KeySource
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Scott T. Hatakeyama
Director, Inventory Management and Optimization
Kaiser Permanente
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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
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Ullrich Mayeski
Director of Community Engagement
GS1 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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Tish E. Pahl
Principal
Olsson Frank Weeda Terman Matz PC
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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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9:45 AM - 9:55 AM
Movement Break
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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
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Justin Macy
Director of Innovation
National Association of Boards of Pharmacy®
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Julie Malone
Regulatory Affairs Manager
Value Drug Company
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David G. Mason
Supply Chain Compliance and Serialization Lead
Novartis Pharmaceuticals Corporation
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Jaidalyn Rand
Director, Industry Relations
Healthcare Distribution Alliance
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Herbert Wong
Chief Customer Officer
Antares Vision Group
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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
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Ilisa B.G. Bernstein
President
Bernstein Rx Solutions, LLC
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Jennell Bilek
Equity Partner
Carlson Caspers IP Litigation & Counseling
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Kala Shankle
Vice President, Regulatory Affairs
Healthcare Distribution Alliance
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Chris Smith
Senior Counsel
Epstein Becker & Green, P.C.
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Theodore Sullivan
Partner
Quarles & Brady LLP
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