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Track-and-Trace Technology Seminar
Monday, November 12—Wednesday, November 14, 2012
Renaissance Arlington Capital View Hotel
Arlington, Va.
Seminar Overview
With the deadline for track-and-trace implementation approaching for California in 2015, this program continues efforts to provide all segments of the healthcare supply chain an opportunity to come together to explore and discuss practical actions the industry is taking as they proceed along the path toward implementation. This seminar will help you stay abreast of the how Congress, FDA and industry stakeholders are addressing evolving pedigree and serialization regulations in the U.S. — along with the potential for federal pedigree. In addition, 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 use track-and-trace data? Find answers to this question and more as you learn how trading partners are working together both up and downstream.
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
Preliminary Program Agenda
| 4:00 PM |
Registration Opens |
| 4:30 PM–6:00 PM |
Serialization Impacts on Packaging Lines
As product manufacturers require serialization capabilities to address California e-pedigree law and upcoming European legislations, hear real use cases of serialization implemented on various packaging lines. This presentation will also share a case study on how to record the aggregation in a bottle bundle. Learn the impacts of serialization for validation, label control and IT.
Speaker: Jean-Pierre Allard, Product Manager - Serialization, Optel Vision |
| 6:00 PM–7:00 PM |
Networking Reception and Table-Top Exhibits |
| 7:00 PM |
Open Evening |
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| 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 |
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 about the most recent legislative and regulatory developments as well as efforts within the supply chain community.
Speaker: Elizabeth A. Gallenagh, Esq., Vice President, Government Affairs and General Counsel, HDMA |
| 9:30 AM–10:15 AM |
Preparing for 2015: California Pedigree Update
Learn more about the California Board of Pharmacy’s expectations for the industry as the deadline for track-and-trace implementation approaches in 2015. Proposed regulations have been released for comment on a unique identifier and on grandfathering. The board is also working on inference.
Speaker: Virginia Herold, Executive Officer, California State Board of Pharmacy |
| 10:15 AM–10:30 AM |
Networking Break and Table-Top Exhibits |
| 10:30 AM–11:15 AM |
Planning for Aggregation: Panel Discussion
This panel discussion will review the challenges and successes involved with aggregating items to cases.
Moderator: John Howells, Senior Director, Industry Relations, HDMA
Panelists: Kimberly Fleming, Senior Manager, Product Security, EMD Serono, Inc.
Lloyd Mager, Track & Trace Program Manager, Abbott Laboratories, Inc., Pharmaceutical Products Div.- Dist Ctr |
| 11:15 AM–12:00 PM |
Manufacturer Insights on Implementation
Gain a manufacturer's perspective on the challenges, opportunities and lessons learned on how they are successfully working together with their trading partners to implement serialization and track-and-trace technology.
Speaker: Thomas J. Pizzuto, Director of End-to-End Traceability, Johnson & Johnson Health Care Systems, Inc. |
| 12:00 PM–1:15 PM |
Networking Luncheon and Table-Top Exhibits |
| 1:15 PM–2:00 PM |
Distributor Perspectives on Preparing for Implementation
Learn how supply chain partners are successfully working together on track-and-trace technology pilot programs as they work toward pedigree implementation in California. Hear about tactics, timelines and action steps they are taking. These real-world examples will provide valuable insights, innovative approaches and lessons learned as the journey continues.
Speakers: Julie Kuhn, Director, Regulatory Management, Cardinal health, Inc.
Steve Tadevich, Director, Product Serialization techologies, McKesson Corporation |
| 2:00 PM–2:45 PM |
State of the Standards/GS1 Update
Trading partners from the healthcare supply chain are actively working within GS1 to further develop standards for track-and-trace technologies to enhance patient safety and improve operations. This session will provide a timely update on Unique Identification Numbers and Track-and-Trace Standards. GS1 will review how the standards can be used and how companies can get involved in the standards development process.
Speaker: MJ Wylie, Senior Director, Medical Devices Segment Lead, GS1 US |
| 2:45 PM–3:00 PM |
Networking Break and Table-Top Exhibits |
| 3:00 PM–3:45 PM |
International Perspectives: Global Track-and-Trace Efforts and the Industry’s Response
Learn about the global requirements manufacturers face to comply with serialization requirements internationally.
Speaker: Tim Marsh, Technology Manager, Global Package Technology, Pfizer Inc. |
| 3:45 PM–4:30 PM |
Pharmacy Perspectives: Advancing Supply Chain Security
The panel session will look at implementing the California pedigree law from the retailer perspective. The panelists will discuss issues, challenges and potential opportunities being considered by retailers as they develop plans for implementing in California in 2017.
Moderator: Elizabeth A. Gallenagh, Esq., Vice President, Government Affairs and General Counsel, HDMA
Panelists: Diane Darvey, Director, Federal & State Public Policy Government Affairs, National Association of Chain Drug Stores
Ed Kaleta, Senior Director, Federal Government Relations, Walgreens
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| 4:30 PM–6:00 PM |
Networking Reception and Table-Top Exhibits |
| 6:00 PM |
Open Evening |
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| 7:30 AM–8:30 AM |
Continental Breakfast |
| 8:30 AM–9:15 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 help further secure the drug supply and enhance patient safety. This presentation will update attendees on initiatives surrounding supply chain safety, cargo security and the continued challenges of healthcare supply chain.
Speaker: TJ Christl, Acting Office Director, Office of Drug Security, Integrity and Recalls, CDER, U.S. Food and Drug Administration |
| 9:15 AM–10:00 AM |
Roundtable Discussions:
Preparing for California
The California pedigree law highlights several areas which allow for potential regulation by the Board of Pharmacy. Among these are interoperability, authentication and data management. 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. |
| 10:00 AM–10:45 AM |
Perspectives from an End-to-End Pilot on Track and Trace
Hear perspectives of what end-to-end track-and-trace implementation might look like, and how it could change the way companies think about supply chain partnerships as the deadline for implementation approaches.
Speakers: Chris Chandler, Pharmacist Consultant, Bar Code Resource Office, VHA Office of Informatics & Analytics, Health Informatics, U.S. Department of Veterans Affairs
Margot H. Drees, Executive Director, Global Startegy, Global Healthcare Exchange, LLC (GHX)
Krystyna Duch, Project Manager, Abott Laboratories, Inc., Pharmaceutical Products Div.
Kevan MacKenzie, Senior Solutions Analyst, McKesson Corporation |
| 10:45 AM–11:00 AM |
Looking Forward
This seminar concludes with an open discussion about insights gained from the presentations, potential forward-looking actions the industry could take, as well as the resources needed to prepare for implementation. |
| 11:00 AM |
Adjournment |
*Agenda subject to change.
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