Unique Device Identification (UDI) systems are rapidly becoming a reality for medical devices and in vitro diagnostics (IVDs). The US Food and Drug Administration (FDA) rule on UDI, published at the end of September 2013 is the first detailed system from a major regulator to lay out the requirements for UDI within the medical technology sector. This rule covers both labelling and the UDI database aspects. Compliance with FDA requirements will be a key priority for EU based manufacturers because anticipated EU legislation is likely to closely follow the US model.

ABHI is offering a unique insight for UK companies in a one day seminar to be led by Jay Crowley, Vice President of UDI practice at USDM Life Sciences. Until recently Jay led the FDA development of UDI regulation. The first half of the day at this important event will be devoted to compliance with the FDA’s final rule while the afternoon session will address specific UK market and NHS requirements. The seminar will also see the UK launch of a new implementation guide which will provide step by step advice on UDI implementation.

Why You Should Attend this Seminar

• Get the latest information on US FDA UDI implementation requirements from our seminar session leader Jay Crowley, Vice President of UDI practice – USDM Life Sciences
• Understand what the US FDA require for regulatory compliance 
• Hear about legal aspects of UDI implementation from a leading regulatory compliance lawyer
• Learn about the upcoming NHS requirements (which will be reality even before the new EU regulations are implemented) 
• And be the first to benefit from a new IMPLEMENTATION GUIDE developed by Eucomed for the MedTech Industry

Exchange views in an interactive setting where participants can ask questions about UDI implementation in the United States and in the UK market.

This UK specific seminar is closely linked to a Eucomed/EDMA event on the following day in Brussels at which Jay Crowley will also be speaking.

Agenda

09.30 Registration, Tea & Coffee

10.00 Welcome

Mike Kreuzer OBE, Executive Director – Technical & Regulatory, ABHI

10.05 Chairman’s Welcome and Introduction

Ulrike Kreysa, Vice-President Healthcare, GS1 Global Office, GS1

10.15 UDI for medical devices in the EU: Legal obligations and implications for manufacturers and the supply chain

Shuna Mason, Head of Regulatory, CMS Cameron McKenna LLP

10.45 Final FDA Rule – Focus on Labelling/Marking

Jay Crowley, Vice President of UDI practice at USDM Life Sciences

Please note that this session will be delivered by Jay Crowley with comments for clarification from two industry experts.

Industry Expert Observations
Jenny Gough, GS1 Specialist Supply Chain Development, Molnlycke Health Care
Simon Richards, VP, Alere

Q&A 11.45

Break

12.00 Draft Guidance on Global Unique Device Identification Database

Jay Crowley, Vice President of UDI practice at USDM Life Sciences

Please note that this session will be delivered by Jay Crowley with comments for clarification from two industry experts.

Industry Expert Observations:
Jenny Gough, GS1 Specialist Supply Chain
Development, Molnlycke Health Care
Andrew Rutter, Senior Regulatory AffairsAssociate, Ortho Clinical Diagnostics and ChairEDMA UDI Task Force

Q&A 13.00

Lunch

14.00 UK Market Implementation –

NHS UDI Requirements
NHS UDI Strategy

Stephen Graham, eProcurement Lead,
Department of Health

GS1 Solutions for the NHS
Roger Lamb, Healthcare Sector Manager, GS1 UK

UDI – Hospital implementation
Alan Hoskins, Director of Procurement and Commercial Services at NHS South of England Procurement Services

Panel Discussion with
Andy Crosbie, Head of Biosciences and Implants Unit, MHRA, UK

15.30 Coffee Break

15.45 Implementation Guide

Jenny Gough
GS1 Specialist Supply Chain Development,
Molnlycke Health Care

Andrew Rutter
Senior Regulatory Affairs Associate, Ortho Clinical Diagnostics and Chair EDMA UDI Task Force

16.15 Conclusion and Closing remarks

Ulrike Kreysa
Vice-President Healthcare, GS1 Global Office, GS1

16.30 Seminar Close

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