UDIs & Traceability. for Medical Devices. The Only European Forum Dedicated to UDIs Will Enable You to:

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assess the financial impact on your business and develop a strategy for practical implementation of UDIs & Traceability The Only European Forum Dedicated to UDIs Will Enable You to: Hear keynotes

1 FDA and EU Commission keynotes on compliance! UDIs & Traceability for Medical Devices Featuring Keynotes from: Conference: 25th - 26th September 2013 Workshop Day: 24th September 2013 Munich, Germany Comply with new international regulations, assess the financial impact on your business and develop a strategy for practical implementation of UDIs & Traceability The Only European Forum Dedicated to UDIs Will Enable You to: Hear keynotes from the FDA and European Commission to understand what is required for regulatory compliance Benefit from manufacturer case studies by early UDI adopters: Learn from the successes and pitfalls Identify the gaps in your current technology and infrastructure and learn how to close them Realise the additional business benefits of implementing UDIs beyond simply regulatory compliance and supply chain visibility Get the other side of the story - presentations from hospital end users and standards organisations; all key stakeholders in UDIs and traceability Benchmark and network with your peers, experts and competitors with over 5 hours of exclusive networking and interactive discussions Workshop Day: 24th September 2013 Implementing a UDI Project This interactive workshop on UDI implementation will expand on the practical processes to implement a UDI project. The session has been developed to help manufacturers develop a practical implementation strategy they can take back to the office to get a head start with their internal UDI project. International Expert Speakers & Leaders Including: Jay Crowley, Senior Advisor for Patient Safety, CDRH, FDA Laurent Selles, Health & Consumer Directorate General, EUROPEAN COMMISSION Ulrike Kreysa, Vice President, Healthcase, GS1 Global Office Géraldine Lissalde-Bonnet, Public Policy Manager, GS1 Global Office Kevin Stout, Executive Director and Founder, Medical Device Supply Chain Council (MedSC LLC) Karen Conway, Executive Director, Industry Relations, GHX David Leedam, Head Global ecommerce, Siemens Healthcare Diagnostics Dawn Fowler, Sr. Manager, Labeling & Documentation, Endologix Chuck Franz, Chief Information Officer, Cook Group Mark Wasmuth, CEO, GMDN Agency Elke Barsties, Manager, Regulatory Affairs, Dentsply Devices Inge Ørnhøj, Senior Process Improvement Manager, Supply Chain Process Improvement, Coloplast Heinrich Oehlmann, Chairman TC, European Health Industry Business Communications Council (EHIBCC) Andrew Smith, HSSU department, St James s Medical

2 Workshop Day: 24th September 2013 Practical Workshop: Implementing a UDI Project 10:00 12:30 This interactive workshop on UDI implementation will expand on the practical processes to implement a UDI project and will cover: Barcode Format Options Labeling Space Evaluation of Size, Spacing and Positioning Direct Part Marking Impact UDI Project Assessment, Development and Execution - Large Scale Company versus Small Company Approaches - Impact on Current Sustaining Product and New Product Development - Building Sustainable, Repeatable Processes for Long Term - Inventory & Distribution Considerations Project Implementation: Process, Successes and Pitfalls Barcode Labeling Equipment Options How do I determine how much this will cost? This session has been developed in order to help manufacturers design and develop a practical implementation strategy they can take back to the office following the event in order to get a head start with their internal UDI project. Dawn Fowler, Senior Manager, Global Labelling & Documentation, Endologix Inc. About the Workshop leader Dawn Fowler is the Senior Manager of Global Labelling & Documentation at Endologix Inc., in Irvine California. She has 30 + years of Quality experience in the pharmaceutical and medical device industries and is an acknowledged expert in global labelling processes, technologies and standards including in-line printing and AIDC technologies. She has expertise in designing, validating and implementing global labelling systems utilizing both linear and 2D barcodes as well as RFID technology for in-line production verification, external customer and global regulatory requirements. Prior to joining Endologix, Inc., Dawn worked with Edwards Lifesciences as the business process owner for Global Labelling and recently completed a large-scale global label conversion project, including design and deployment of barcode processes and technology to prepare for upcoming global UDI requirements. Dawn is a member of several groups focused on AIDC, UDI, product standards development and implementation including AdvaMed, GS1US, GS1 Global, HL7 and MedSC. Partner with us! Maximize Your Involvement: Sponsorship and Exhibition Opportunities Clinical Trial Supply USA is attended by senior officials and decision-makers from industry, bringing together buyers and suppliers in one location. Focused and high-level, the event will be an excellent platform to initiate new business relationships. With tailored networking, sponsors can achieve the face-to-face contact that overcrowded trade shows cannot deliver. Exhibiting and Sponsorship options are extensive, and packages can be tailor-made to suit your individual company s needs. Most packages include complimentary entry passes, targeted marketing to industry officials and executives, and bespoke networking opportunities. Other features of sponsorship include: Prominent exhibition space in the main conference networking area Participation in comprehensive pre-event marketing campaigns Tailored marketing strategies to suit your organization s size, capabilities and individual requirement For more information and to discuss the right opportunity, contact us on +44 (0) or sponsorship@iqpc.co.uk Who Should Attend? Senior Vice President, Vice President, Executive Director, Director, Associate Director, Head and Manager from departments including: Regulatory Affairs Supply Chain IT Manufacturing Distribution Product Security Anti- Counterfeiting Logistics Quality Assurance From companies including: Medical Device Manufacturers Hospitals and Medical Practices Government and regulatory officials You can access a variety of free resources such as whitepapers, articles, news, podcasts and presentations online at

3 08.15 Registration & Networking Coffee Chairman s Opening Remarks Day One: 25th September 2013 STATE OF THE INDUSTRY: WHERE ARE WE NOW? Opening Keynote: Are We There Yet? Driving Standards Within the Healthcare Supply Chain Discussing strategic planning and execution to drive market collaboration Global standards: reality or pipedream? Adoption and implementation GTIN attribution, publication and dissemination Chuck Franz CIO Cook Group UDI Implementation Support by Health Care Bar Code (HIBC) The HIBC UDI construct for efficient product identification One product - One number What s new: Internet of Things (IoT) linked by HIBC product code, learning from success of QR Code GMDN class code embedded in a UDI code; features & benefit UDI in practical use for optimising clinical processes; application example UDI & RFID supporting device sterilisation processes Heinrich Oehlmann Chairman TC European Health Industry Business Communications Council (EHIBCC) Networking Lunch STANDARDS, REGULATIONS & COMPLIANCE UDI: The Global Value Proposition UDI is a global phenomenon, with regulators around the world in various stages of drafting or implementing regulations that will require manufacturers to label their products with unique identifiers and provide additional data about those products to UDI databases. How can global manufacturers best prepare for the regulations, when there is still so much uncertainty in various markets? More importantly, how can manufacturers turn what will essentially be a required investment into a value proposition for themselves and their customers? UDI regulation around the world The US experience Pending European regulation Creating a globally harmonised approach Karen Conway Executive Director, Industry Relations GHX Solution Spotlight: Preparing for UDIs Key Technical Considerations to Factor in Now This session is available for a leading provider - if you think your service would be of interest to our delegation, get in touch on +44 (0) or sponsorship@iqpc.co.uk Speed Networking Networking Coffee Break An International Database: Harmonising Terminology & Entries Across Borders What is the GMDN and how does it fit into the UDI big picture? GMDN term structure & data elements How GMDN can help manufacturers far beyond ticking the UDI box Looking at how manufacturers have responded to UDIs and GMDN Mark Wasmuth CEO GMDN UDI: Soon is now UDI what does it mean for the Medical Device industry? Global standards to fulfill UDI requirements Implementation the easy and the difficult part Regulatory developments worldwide on UDI Ulrike Kreysa Vice President, Healthcare GS1 Global Office UDI Deployment Guidance: the IMDRF and European Commission EU COMMISSION Perspectives Reviewing the IMDRF guidance on UDI labelling The roadmap for implementation Discussing the European recommendation for UDIs What next? The future of UDIs for medical device manufacturers Laurent Selles Health & Consumer Directorate General European Commission and Chair of the UDI Working Group IMDRF Networking Coffee Break The FDA s UDI Programme: Updates on the Final Rule Changes from the proposed to the final rule New parts to the final rule The development and use of the GUDID FDA Q&A Opportunity Jay Crowley, Senior Advisor for Patient Safety, CDRH FDA (via remote link) Panel Discussion: A Harmonised Approach UDI and Data Standardisation Internationally With data storage and submissions being a key component of the UDI initiatives, the format this data is stored in makes a big difference on an international level whether we re dealing with one database for the EU, or 27! How stakeholders can help each other to plan for UDIs The realities of data standardisation on this scale practical or not? Coordinating a rollout/implementation between stakeholders Senior representatives from: FDA, EU Commission, GS1 and GMDN 17:50 Chairman s Summary and Close of Day One

4 Day Two: 26th September Registration & Networking Coffee Chairman s Recap on Day UDI Traceability from a CDU Perspective: CASE STUDY Challenges & Opportunities Piloting a national surgical instrument set tracking system using GS1 coding The development of this system to include device manufacturers providing loan sets between hospitals The potential for incorporating unique device traceability into this system The risks and benefits which may arise from this progression Andrew Smith HSSU Department St James s Medical MANUFATURER CASE STUDIES: IMPLEMENTATION OF UDIs AND PRODUCT DATABASES UDI Path and Pitfalls CASE STUDY The challenge of UDI in a diverse global business with multiple product lines and manufacturing plants Medical Device or not Medical Device? Where & when to apply the UDI, and the challenge with IVDs Looking between the cracks: are there any areas of the business that aren t affected? Major considerations, such as logistics, lead times and stock levels Don t Panic : where do I start? David Leedam Head, Global ecommerce Siemens Healthcare Diagnostics Networking Coffee Break How to Implement UDI Information CASE STUDY on a Medical Device Determining methods for the planning and execution of a UDI labeling project Evaluating and determining the key components, planning and execution of a UDI project Developing a top-line strategy to achieve executive funding and support for a UDI labeling project Review UDI project case study Dawn Fowler Sr. Manager, Labeling & Documentation Endologix From Pilot Project to Implementation CASE STUDY Identifying the Gaps and Solving them Running a UDI pilot project: getting started Discussing lessons learned from the project, and where the obvious and not so obvious gaps are Developing a strategy to close the gaps identified Beginning full-scale rollout and implementation Inge Ørnhøj, Senior Process Improvement Manager, Supply Chain Process Improvement Coloplast Networking Lunch KEY UDI & TRACEABILITY CONSIDERATIONS Panel Discussion: Data Standards at the Heart of UDIs The role of data in the UDI FDA regulations and proposed EU framework The practicalities of an international or even global database Developing a global, flexible and integrated strategy that factors in national exceptions Facilitated by members of the speaker faculty Developing a Strategy for the Implementation of UDI History: from GHTF Recommendation to US and EU Regulation Principle Structure of UDI system (static part, dynamic part, components) Your gap analysis: - Additional information required to provided - How to communicate the static part - Choice of the most appropriate machine readability standard - Infrastructure Elke Barsties Manager, Regulatory Affairs Dentsply Devices Networking Coffee Break Interactive Roundtable Discussions Roundtable A Establishing a Cross: Functional Stakeholder Project Team Gaining the Buy-In Roundtable B Supply Chain Focus: Changes to labelling, manufacturing and supply chain Roundtable C Master Data Management: Handling the data and database submissions for UDIs 16:20 Roundtable Summary Presentations Nominated leaders from each roundtable will present the key learning points from their group to the rest of the audience, for the benefit of those who attending different breakout groups Chairman s Closing Summary Close of Conference Website: Phone: +44 (0) Delivering quality content and events to enhance your knowledge and strengthen your networks Healthcare IQ, a division of IQPC, is dedicated to providing practical, detailed information through conferences and training courses held at both the national and international level. By providing accurate, objective and up-to-date developments and trends, Healthcare IQ enables organizations to remain competitive and profitable. Become a member here:

5 UDIs & Traceability for Medical Devices My registration code PDFW Please contact our database manager on +44(0) or quoting the registration code above to inform us of any changes or to remove your details. Delegate Details - Simply complete this form and Click submit Please photocopy for each additional delegate Mr Mrs Miss Ms Dr Other First Name Conference + Workshop Conference only Workshop only Audio recordings Family Name Tel No. by 14th June* 2,198 +VAT Save 350 1,649 +VAT Save 250 by 12th July* 2,298 +VAT Save 250 1,749 +VAT Save 150 Yes I would like to receive information about products and services via IQPC Point of contact Conference: 25th - 26th September Workshop Day: 24th September Munich, Germany 649 +VAT 550 +VAT * To qualify for discounts, payments must be received by the early bird registration deadline. Early booking discounts are not valid in conjunction with any other offer. German VAT is charged at 19%. 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