Through practical case studies and industry specific analysis sessions, Medical Device UDIs & Traceability Forum Europe 2015 is geared around strengthening your regulatory infrastructure, maintaining productivity and ensuring ROI from your UDI projects. View the full agenda here: bit.ly/MedicalDeviceUDI2015Agenda Alternatively, email enquire@iqpc.co.uk or call +44 (0)207 036 1300 for a copy.

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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,
FDA
Andrew Rutter,
Senior Regulatory Affairs Associate,
EDMA UDI Task Force,
Ortho-Clinical Diagnostics
David Brooks,
Senior UDI Project Manager,
Covidien
Craig Karagitz,
Project Manager,
Terumo
Bianca Maria Gravenhorst Greve,
Senior Regulatory Affairs Manager -
Global Operations,
Coloplast
Geraldine Lissalde-Bonnet,
Senior Public Policy Manager,
GS1 Global Office
Chuck Franz,
Chief Information Officer,
Cook Medical
Erin Fields,
Program Analyst,
FDA
Inge Ornhoj,
Senior Process Improvement Manager,
Coloplast
Pia Withenstein,
Regional Project Manager,
Clinical Engineering Region of
Southern Denmark
Jenny Gough,
GS1 Specialist Supply Chain
Development,
Molnlycke Health Care
Dawn Fowler,
Senior Manager, Labeling
Documentation,
Endologix
Edward Glenn,
Term developer - GMDN Data,
GMDN Agency
Ani Goverde,
QA/RA EMEA,
NDS Surgical Imaging BV
Funda Ozdiler Çopur,
Biomedical Engineer,
Turkey Medicine Medical Devices
Agency
Featured presentations from leading
experts in the industry include:

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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 Alere
Ahead 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 Interoperability
In 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 Calendar
Ahead 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