Featured Speakers:

Erin Fields
Program Analyst
FDA
Andrew Rutter
Senior Regulatory Affairs Associate, EDMA UDI Task Force
Ortho-Clinical Diagnostics
FDA
Indira Konduri
GUDID Program Manager
FDA
David Brooks
Senior UDI Project Manager
Covidien
Geraldine Lissalde-Bonnet
Senior Public Policy Manager
GS1 Global Office
Funda Ozdiler Çopur
Biomedical Engineer
Turkey Medicine & Medical Devices Agency
Inge Ornhoj
Senior Process Improvement Manager
Coloplast
Bianca Maria Gravenhorst Greve
Senior Regulatory Affairs Manager - Global Operations
Coloplast
Pia Withenstein
Regional Project Manager
Clinical Engineering Region of Southern Denmark
Edward Glenn
Term developer - GMDN Data
GMDN Agency
Ani Goverde
QA/RA EMEA
NDS Surgical Imaging BV
Chuck Franz
Chief Information Officer
Cook Medical

Welcome to Medical Device UDIs & Traceability Forum Europe 2015

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

Patient safety is of paramount importance in the medical device industry. With the FDA’s final rule on UDIs out and the first class III deadline having passed, the stage has been set for future deadlines, and medical device manufacturers have to improve their products tracking and traceability as they travel through the supply chain.

On the 9th April 2013 the European Commission published a framework that sets out a harmonized approach with the FDA on UDIs in Europe. In the next year or so, UDIs will become enforced globally.

The current and future reality is that the regulatory elements of medical technology are now just as important as how the product is designed, manufactured and marketed. This means upgrading or purchasing new labelling, printing, packaging and IT solutions that comply with the final rule on UDIs.

Medical device manufacturers have to work towards a full UDI compliance and implement UDIs requirements in order to maintain productivity and ultimately survive in this competitive industry.

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 UDIs projects.

Why Should You Attend?

1. Learn how to assess the global regulatory landscape – How do you fit in? What does it mean for European medical device manufacturers? How do you set yourself up for future regulations?
2. Discover how to manage the financial barrier and assess the right type of UDI technology
3. Uncover the complexity of implementing UDI and validate your existing labeling and packaging against FDA UDI, GDSN and custom validations – filling the gaps
4. Meet regulatory requirements to improve business initiatives, reduce costs and enhance business processes throughout the supply chain
5. Learn how to develop a UDI corporate policy and strategy across all business units and departments

Who will you meet at Medical Device UDIs & Traceability Forum Europe 2015?

  • 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

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