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Track-and-Trace Technology Seminar

Wednesday, November 9–Friday, November 11, 2011
Gaylord National Resort & Convention Center
National Harbor, Md.


Seminar Overview

New technology, changing regulations and impending deadlines have led to a business climate that demands you stay abreast of the latest industry developments surrounding the use of track-and-trace technologies in the supply chain.

This seminar continues efforts to provide all segments of the healthcare supply chain an opportunity to assess strategies and industry-wide efforts to move track-and-trace technologies toward implementation in 2015. Review the many evolving regulations, standards, business processes, company pilots and technologies and the practical actions the industry is taking to work toward compliance.

Meet with your trading partners and industry experts to:

  • Explore the impact of the latest regulations, standards, business processes and technologies;
  • Find out the practical, collaborative actions the industry is taking to make the most of this rapidly-changing environment;
  • Learn from your peers and trading partners as they share their experiences through case studies and pilot projects; and
  • See the latest track-and-trace solutions at the seminar’s table-top exhibits.

Presentations will highlight such special interest areas as understanding existing and potential regulations, end-to-end supply chain track and trace, international perspectives on serialization, data management, distributor insights into material handling and other key topics. The program concludes with a forward-looking examination of benefits the industry could receive from implementing serialization and track-and-trace technologies.

Target Audience

This seminar is a must-attend for pharmaceutical distributors, manufacturers and retailers seeking to explore and discuss implementation strategies and the latest industry developments surrounding the use of track-and-trace technologies in the healthcare supply chain.

Seminar Sponsors

click here to visit Acsis's website click here to visit Axway's website  
click here to visit OM HealthCare Logistics' website click here to visit Seidenader's website  

Supporting Organizations

click here to visit ASHP's website

Preliminary Program Agenda

Wednesday, November 9
4:00 PM Registration Opens
4:30 PM–6:00 PM

Opening Business Session
Serialization and Aggregation: Manufacturer Insights
The process of implementing item level serialization and aggregation is one of the most important strategic investments made by many manufacturers. This opening business session will provide valuable insights from one manufacturer on how they are overcoming the issues and challenges associated with the physical and process changes that take place for incorporating it into their production lines. Finally, this session will outline lessons learned and factors to be considered when rolling out serialization with potentially different regulatory requirements and business drivers.

Speaker: Michelle L. Keller, Associate Director, Customer Operations, TEVA Pharmaceuticals USA

6:00 PM–7:00 PM Networking Reception and Table-Top Exhibits  
7:00 PM Open Evening
Thursday, November 10
7:30 AM–8:30 AM Continental Breakfast 
8:30 AM–8:45 AM Welcome and Introductions
Perry Fri, Senior Vice President, Industry Relations, Membership & Education, HDMA
8:45 AM–9:30 AM

FDA Perspectives on Supply Chain Safety Initiatives
The U.S. Food and Drug Administration (FDA) is involved in a number of supply chain safety initiatives that support the use of technology to aid in further securing the drug supply and enhancing patient safety. This presentation will provide an update on initiatives surrounding supply chain safety, cargo security and the continued challenges from globalization of the healthcare supply chain.

Speaker: Karen Rothschild, Esq., Regulatory Counsel, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

9:30 AM–10:15 AM

International Perspectives on Serialization
Serialization has been implemented differently in other countries. Keeping abreast of these requirements for authentication and track-and-trace and the potential impact on implementation efforts in the U.S. healthcare supply chain is important to your business.

Speaker: Caroline Dunn, Engagement Manager, IMS Health, Inc.

10:15 AM–10:30 AM Networking Break and Table-Top Exhibits 
10:30 AM–11:15 AM

GS1 Drug Pedigree Messaging Standards v. Serialized Advanced Ship Notices
With the deadline for track-and-trace implementation approaching, this session compares two transactions — the GS1 Drug Pedigree Messaging Standard and the Serialized Advanced Ship Notices — for tracking and tracing items in the pharmaceutical supply chain. Hear a top-line comparison along with other factors to take into consideration.

Speakers: Steve Tadevich, Director, Account Management, McKesson Corporation
Robert C. Young,
Associate Director Delivery Management, TEVA Pharmaceuticals USA

11:15 AM–12:00 PM

Manufacturer Serialization Insights and Opportunities
Learn how manufacturers are successfully working together with their trading partners to implement serialization and track-and-trace technology. Learn about the challenges, opportunities and lessons learned in implementing serialization as they proceed along the path toward implementation. These real-world examples provide valuable insights into innovative approaches and lessons learned.

Speakers: Mike Rose, Vice President, Supply Chain Visibility, Johnson & Johnson Health Care Systems, Inc.
Peggy Staver, Director, Product Integrity, Pfizer Inc.

12:00 PM–1:00 PM Networking Luncheon and Table-Top Exhibits 
1:00 PM–1:45 PM

Preparing for 2015: California Pedigree Update
The afternoon will continue with a regulatory overview on the state of pedigree law in California. Learn more about the California Board of Pharmacy’s expectations for the industry as the deadline for track-and-trace implementation approaches in 2015.

Speaker: Virginia Herold, Executive Officer, California State Board of Pharmacy

1:45 PM–2:30 PM

Data Management
With the growth of data exchanged to support track-and-trace, the healthcare supply chain continues to raise important questions. What is the best way to exchange, capture, and utilize track-and-trace data? Find answers to this question and more as you learn how trading partners are working together both up and downstream.

Speaker: Julie Kuhn, Director, Regulatory Management, Cardinal Health, Inc.

2:30 PM–3:15 PM

Global Healthcare Exchange: Track-and-Trace Prototype
Global Healthcare Exchange (GHX) and a group of its owners have been working on a prototype of a Track and Trace System that leverages the GHX Exchange, GS1 Standards and will allow pharmaceutical trading partners to enhance patient safety, meet regulatory compliance mandates and derive additional business benefits. This presentation will highlight how the prototype demonstrates a couple of the GS1 Network Centric ePedigree (NCeP) models and discuss next steps including pilot programs.

Speakers: Ron Bone, Senior Vice President, Distribution Operations, McKesson Corporation
Margot H. Drees, Director, Corporate Strategy, Global Healthcare Exchange
Mike Rose, Vice President, Supply Chain Visibility, Johnson & Johnson Health Care Systems, Inc.

3:30 PM–4:15 PM

UPS Serialization Pilot Project and Discussion
Learn how United Parcel Services (UPS) Supply Chain Solutions has been working over the past several years to develop an internal serialization strategy to comply with California law for pharmaceutical manufacturer and distributor companies. Gain valuable insights and lessons learned into the evolution behind the development of UPS SCS’s serialization capabilities and solutions and how they have addressed and continue to work challenges along the path.

Speaker: Tim Bishop, QA Senior Manager, UPS Supply Chain Solutions

4:15 PM-5:00 PM

Roundtable Discussions
Preparing for California: Inference, Grandfathering and Drop Shipments

The California pedigree law highlights several areas which allow for potential regulation by the Board of Pharmacy. Among these are grandfathering, drop shipments and inference. Learn from your peers and exchange industry ideas about compliance in light of the logistical issues. Please come prepared to discuss your company’s perspective on the challenges you face for implementation during the fast-paced roundtable discussion.

5:00 PM–6:00 PM Networking Reception and Table-Top Exhibits   
6:00 PM Open Evening

Friday, November 11

7:30 AM–8:30 AM

Continental Breakfast 

8:30 AM–9:15 AM

Federal Pedigree Update
The existing patchwork of state pedigree laws continues to challenge manufacturers and distributors alike as they strive to preserve efficiencies in the supply chain. Learn more about the most recent legislative and regulatory developments and what Congress, FDA and industry stakeholders are doing to address this at the federal level.

Speaker: Elizabeth A. Gallenagh, Esq., Vice President, Government Affairs and General Counsel, HDMA

9:15 AM–10:00 AM

Retail Perspectives on Track-and-Trace
Hear insights on how retailers are utilizing serialized products in the pharmacy setting. Learn more about the corresponding operational benefits such as inventory control, expiration date management, dispensing accuracy, work-flow improvement and patient compliance.

Speaker: Diane L. Darvey, PharmD, JD, Director, Federal and State Public Policy, National Association of Chain Drug Stores

10:00 AM–10:30 AM

End State Vision
This session will present a vision of what end-to-end track-and-trace implementation might look like, and the ways it could change how companies think about supply chain partnerships as the deadline for implementation approaches.

Panelists: Ron Bone, Senior Vice President, Distribution Operations, McKesson Corporation
Peggy Staver,
Director, Product Integrity, Pfizer Inc.

10:30 AM–11:00 AM

Looking Forward
This seminar concludes with an open discussion about insights gained from the presentations and potential forward looking actions the industry could take, as well as resources needed to prepare for implementation.

Perry Fri, Senior Vice President, Industry Relations, Membership & Education, HDMA

11:00 AM


*Agenda subject to change.


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