Seminar Sponsors

Monday, November 8

4:00 PM

Registration Opens

4:30 PM–6:00 PM

Opening Business Session — Serialization and Data Management
What is the impact of serialization on packaging operations? This session examines the paradigm shift serialization has caused in the packaging environment. Learn about issues and considerations at the device, line and plant levels when moving from traditional packaging to serialized packaging. This session also will outline the technology architecture required to support serialization data (while maintaining packaging line throughput). Examine lessons learned and factors to be considered when rolling out serialization across multiple locations with different regulatory requirements and business drivers. 

Speaker: David DeJean, Vice President, Professional Services, Systech International^TM

6:00 PM–7:00 PM

Networking Reception and Table-Top Exhibits
Sponsored by Stericycle ExpertRETURN

7:00 PM

Open Evening

Tuesday, November 9

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 supporting technology use to help further secure the drug supply and enhance patient safety. Hear an update on the Agency’s initiatives surrounding supply chain safety, cargo security and the continued challenges faced due to the globalization of the healthcare supply chain.

Speaker: Ilisa B.G. Bernstein, PharmD, JD, Deputy Director (Acting), Office of Compliance Center for Drug Evaluation and Research, U.S. Food and Drug Administration

9:30 AM–10:15 AM

Preparing for 2015: State and 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 at the state and federal levels. The session also will provide specifics about what lies ahead for pedigree implementation in California.

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

10:15 AM–10:30 AM

Serialization and Visibility in the Supply Chain
The Clinical Laboratory Automated Stockroom System, known as the CLASS Project, was formed to address the need to achieve visibility of product movements across the entire medical device supply chain by implementing GS1/EPC open global standards and EPC Gen 2 tags. This session provides an overview on the first phase of the project. Learn how the CLASS Model Solution using EPC RFID and GS1 datamatrix labels operates successfully within a clinical environment.

Speaker: Jim Bracken, CEO, GS1 Ireland

10:30 AM–11:15 AM

Session topic to be announced

11:15 AM–-12:00 PM

State of the Standards/GS1 Update
Healthcare supply chain trading partners are actively working within GS1 to further develop track-and-trace technology standards to enhance patient safety and improve operations. This session will focus on the standards currently under development, highlight how these standards can be used and how companies can participate in the standards development process.

Speaker: Robert Celeste, Director, GS1 Healthcare US

12:00 PM–1:00 PM

Networking Luncheon and Table-Top Exhibits

1:00 PM–2:00 PM

Authentication vs. Track and Trace: A Comparison of the EU and US
This session compares the different requirements for authentication and track and trace in Europe and the United States, and the potential impact of these requirements on implementation efforts in the U.S. healthcare supply chain.

2:00 PM–3:00 PM

Making the Case: Distributor and Manufacturer Insights
Learn how supply chain partners are successfully working together on track-and-trace technology pilot programs. Hear about the tactics, timelines and action steps they are taking as they work toward implementation. These real-world examples highlight innovative approaches and lessons learned from this process.

Speakers: Michelle Keller, Senior Manager, Marketing, TEVA Pharmaceuticals USA
Kevan MacKenzie, Senior Solutions Analyst, McKesson Corporation

3:00 PM–3:15 PM

Networking Break and Table-Top Exhibits

3:15 PM–5:00 PM

Roundtable Discussion
Roundtable discussions provide an opportunity to learn in small groups by exploring key issues, obstacles and potential solutions. Come ready to share your comments, questions and observations.
Topics include: Standards gap, Benefits of Serialization, Data Exchange, Barriers to Implementation, the Global Data Synchronization Network™ (GDSN) and Inference.

5:00 PM–6:00 PM

Networking Reception and Table-Top Exhibits

6:00 PM

Open Evening

Wednesday, November 10

7:30 AM–8:30 AM

Continental Breakfast

8:30 AM–9:15 AM

Serialization and the "Digital" Pharmaceutical Supply Chain
The digitization of music, video and text has revolutionized how information content is distributed, managed and sold. Serialization will help “digitize” material flows for the very first time, leading to a host of new opportunities and applications that could transform the way pharmaceutical products are handled, marketed and sold. This future-focused session will provide insight into this topic and how activities like inventory management may be impacted by serialization.

Speaker: Robin Koh, Partner, AutoID Consulting

9:15 AM–10:00 AM

Making the Case: Industry Insights
Learn how industry trading partners are using pilot programs to identify and work on the challenges with serialization in the supply chain. Hear about the tactics, timelines, and action steps they are taking as they work toward implementation. These real-world examples highlight innovative approaches, lessons learned and how to effectively collaborate with trading partners.

Speaker: Julie Kuhn, Director, Operations, Cardinal Health, Inc.

Track-and-Trace Information Sharing – Project Summit
Learn about the groundwork being completed by members of the supply chain to develop an industry-wide track-and-trace information-sharing system. How will the supply chain accomplish the vision set forth in the Center for Healthcare Supply Chain Research’s Rules of Engagement: Phase II • The Blueprint for Data Management & Data Sharing? Hear how the Global Healthcare Exchange (GHX) and a group of its owners have been working to define 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 session highlights the work completed to date, and examines the next steps toward building this system.

Speakers: Margot H. Drees, Director, Corporate Strategy, Global Healthcare Exchange, LLC
Michael Rose, Vice President, Supply Chain Visibility, Johnson & Johnson

10:30 AM–11:00 AM

Open Discussion and Wrap-Up
The seminar concludes with an open discussion of the insights gained from the program, potential forward-looking actions the industry could take and the resources needed to prepare for implementation.

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

11:00 AM

Adjournment