T: +44(0)207 036 1300 | E: enquire@iqpc.co.uk | www.udisandtraceability.com

Conference: 27th – 28th May 2015 Pre-Conference Workshops: 26th May 2015 | Munich, Germany

Strengthening Your Regulatory Infrastructure and Improving Your Competitive Presence in the Industry

The 2015 forum will bring you: • A presentation from the FDA on the GUDID Interface and upcoming

Class II deadline

• 7+ Case Studies: Including facilitating regulatory compliance, maximising ROI during UDI implementation, addressing implementation challenges and data availability

• 3 Practical Workshops: Learn how to implement a UDI project while maintaining your productivity and ensuring ROI from top manufacturers

• GS1 UDI Implementation Case Study: Understand the different steps of implementation

The only

event dedicated to

medical device UDIs and

implementation in Europe

Attend the Only Forum Dedicated to Medical Device UDIs and Implementation in Europe to:

• Learn how to assess the global regulatory landscape. How do you fit in? How do you set yourself up for existing and future regulations?

• Discover how to manage the financial barrier and assess the right type of UDI technology

• Uncover the complexity of implementing UDI and validate your existing labelling, printing and packaging against FDA UDI, GDSN and customs validations – filling the gaps

• Meet regulatory requirements to improve business initiatives, reduce costs and enhance business processes throughout the supply chain

• Explore how to develop a UDI corporate policy and strategy across all business units and departments

Indira Konduri, GUDID Program Manager, FDAAndrew Rutter, Senior Regulatory Affairs Associate, EDMA UDI Task Force, Ortho-Clinical DiagnosticsDavid Brooks, Senior UDI Project Manager, CovidienCraig Karagitz, Project Manager, TerumoBianca Maria Gravenhorst Greve, Senior Regulatory Affairs Manager - Global Operations, ColoplastGeraldine Lissalde-Bonnet, Senior Public Policy Manager, GS1 Global OfficeChuck Franz, Chief Information Officer, Cook MedicalErin Fields, Program Analyst, FDAInge Ornhoj, Senior Process Improvement Manager, ColoplastPia Withenstein, Regional Project Manager, Clinical Engineering Region of Southern DenmarkJenny Gough, GS1 Specialist Supply Chain Development, Molnlycke Health CareDawn Fowler, Senior Manager, Labeling & Documentation, EndologixEdward Glenn, Term developer - GMDN Data, GMDN AgencyAni Goverde, QA/RA EMEA, NDS Surgical Imaging BVFunda Ozdiler Çopur, Biomedical Engineer, Turkey Medicine & Medical Devices Agency

Featured presentations from leading experts in the industry include:

T: +44(0)207 036 1300 | E: enquire@iqpc.co.uk | www.udisandtraceability.com

Sponsorship Opportunities

Who will you meet? Visit the Media Centre for complimentary resources:

Maximise Your Involvement: Sponsorship and Exhibition Opportunities Medical Device UDIs and Traceability Europe 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 organisation’s size, capabilities and individual requirement

For more information and to discuss the right opportunity, contact us on +44 (0)207 368 9300 or sponsor@iqpc.co.uk

• Regulatory Affairs• Supply Chain• IT• Manufacturing• Distribution• Product Security• Anti-Counterfeiting• Logistics• Quality Assurance From companies including:• Medical Device Manufacturers• Hospitals and Medical Practitioners• Government and Regulatory Officials• Technology Vendors

Exclusive Interview with Simon Richards from AlereAhead of the UDIs and Traceability for Medical Devices Forum 2014, Simon Richards, VP for Regulatory Affairs, EME at Alere, spoke with us about:

• The benefits of a well-built unique device identification (UDI) system

• Developing a strategy for implementation

• Future perspectives for medical device manufacturers

Balancing Act: Taking a Harmonised Approach to Medical Device Label InteroperabilityIn this exclusive interview Melissa Finocchio, Director, Product Labeling and Documentation BioMerieux, speaks to Andrea Charles about:

• Changing trends in product labelling and documentation for medical devices

• Overcoming barriers to standardisation and BioMerieux’s top 3 priorities now that the FDA Final Rule on UDIs for medical devices is out

THE UDI Final Rule Interactive Compliance CalendarAhead of the Medical Device UDIs & Traceability Forum, the GHP Network has put together this one-page interactive compliance calendar to help you understand what impact the September 2013 FDA Final Rule on unique device identification will have on your business.

Reed Tech offers an industry-leading medical device data management and submission solution for the FDA’s and other regional regulatory authorities’ Unique Device Identifier Databases (UDID). Since the inception of Structured Product Labeling (SPL) in 2005, Reed Tech has been the leading provider of SPL preparation and submission services to over 800 life sciences companies. Reed Tech now applies a decade of experience and expertise to help medical device manufacturers of all sizes fulfill their UDI submission requirements.

The Reed Tech UDID Solution accepts data from manufacturers’ existing repositories via multiple import options, verifies data values per the FDA’s current specifications, builds and submits SPL data messages to the GUDID, and processes the acknowledgement messages – all in a secure, compliant, hosted environment. The proven Reed Tech UDID Solution provides timely, accurate submission and maintenance of GUDID device records in a cost-effective manner and will support future global UDID submissions.

Sponsor

About GHP Network

Global Healthcare Professional Network (GHP Network) is a dynamic new organisation striving to provide truly best practice learning opportunities for senior hospital & healthcare service providers across the globe. Senior management at GHP Network have been researching & developing global healthcare conferences for over 15 years. Over this time they have successfully launched over 350 unique annual healthcare conferences. All of which were specifically designed with & for senior administrators, nurses, clinicians and consultants working within the acute & community healthcare settings. www.ghpnetwork.com