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3rd Annual:

Labelling and Packaging Compliance for Medical Devices & IVDs

Gain essential global regulatory updates

27 - 28 October 2009, Hilton Olympia, London, UK

Your expert faculty includes: · Jay Crowley, Food and Drug Administration (FDA), USA · Jim Willmott, Smiths Medical, UK · Richard J Saunders, Abbott Diabetes Care Ltd., UK · Alois Jochum, Roche Diagnostics GmbH, Germany · Ben Jacoby, Ortho-Clinical Diagnostics, Johnson & Johnson, UK · Holger Most, Kimberly Clark, Belgium · Janice Kite, GS1 Global Office, UK · Joachim Wilke, Medtronic GmbH, Germany · Ian Hooper, Ortho-Clinical Diagnostics, Johnson & Johnson, UK · Roland Back, Bard Europe, UK · Peter Schroeer, Johnson & Johnson, Germany · Karin Listringhaus, Roche Diagnostics Ltd., Switzerland · Toni Kennet Joergensen, Straumann AG, Switzerland · Francesco Laterza, CID (Carbostent & Implantable Devices), Sorin Biomedica Cardio SRL, Italy

t D re t to h his o n g he e o o De ulat US ar ppo t m vic ory F dire rtu iss D c n e Id upd A a tly ity en a bo fr tif tes u om t ic at on ke io U y n ni (U qu DI e )

At this event you will:

Explore essential regulatory updates to the current medical

device labelling regulations ­ be prepared for implementation by March 2010 Gain up-to-date changes to labelling requirements in emerging markets: Turkey, China, Korea, Brazil and Russia Discover new labelling requirements for single use and phthalates containing devices Understand the impact of the REACH and CLP/GHS legislation on labelling for medical devices and IVDs Evaluate the benefits of bar coding and how to successfully implement bar coding using the GS1 Standards Benefit from an in-depth session on Instructions for Use (IFUs) by alternative means and the current EU regulations for electronic IFUs Examine the importance of the use of symbols for labelling ­ what are the advantages and pitfalls? Participate in interactive panel discussions: Share your opinions and get answers to your questions

Plus don't miss Monday 26 October 2009, Pre-Conference Workshop X

Strategies in Regional Labelling

Workshop Leader: Dr Salma Michor, CEO and Principal Consultant, Michor Consulting EU, Austria

Co-located with Pharmaceutical Labelling and Packaging Summit

Conference Sponsor: Media Partners:

To Register Please Tel: +44 (0) 20 7017 7481

Web: www.informa-ls.com/labelling

Fax: +44 (0) 20 7017 7823 Email: [email protected] Please quote CQ7062

"A very informative conference that covered a broad range of subjects related to labelling and packaging compliance," (Abbott Diabetes Care Ltd., 2008 Delegate)

Pre-Conference Workshop X: Monday 26 October 2009

Strategies in Regional Labelling

Registration is at 09:00 for 09:30 start. The workshop will finish no later than 16:00. Lunch and refreshments will be provided.

The information presented on labels comes into direct contact with the consumer and could have far reaching implications. Labelling is a form of communication with the end user. The information presented must be accurate, clear and not misleading. At the same time the labels must conform to the regulatory requirements and standards (EN980 and ISO15223). The workshop will cover the basic principles of forming a sound labelling strategy for regional applications. The following topics will be covered in the workshop: · Regulatory aspects · Use of symbols/standards (EN980 and ISO15223) · Handling multi-language labels/ensuring correct translations

· · · ·

Practical steps to achieving regulatory compliance Use of SOPs and check lists E-labelling Forming a sound regional labelling strategy

Who should attend the workshop? · Regulatory affairs · Quality assurance · R&D · Artwork & labelling Led by: Dr Salma Michor, CEO and Principal Consultant, Michor Consulting EU, Austria

Day One ­ Tuesday 27 October 2009

08.30 09.00 Registration Opening remarks from the Chair 12.35 Lunch

Unique Device Identification (UDI) and Bar Coding

13.40 Keynote Presentation: US FDA Regulatory Update on UDI · Understanding UDI in practical terms · UDI based on global standards · Application to high risk devices and determining what devices are high risk · The deadline and transition period for compliance · Evaluating whether there will be any exemptions Jay Crowley, Senior Advisor for Patient Safety, Center for Devices and Radiological Health, Food and Drug Administration (FDA), USA 14.20 KEYNOTE PRESENTATION The Use of Labelling Systems in Meeting the FDA's Requirement for UDI · The role that smart design and labelling systems can play in meeting these requirements · How these systems can also help in meeting 21 CFR Part 11 for security and electronic signatures · How these systems can help organisations looking to collaborate online with external supply chain partners where packaging and labelling may be performed by a third party Dave Taylor, Product Manager, PRISYMID Limited - RFID, Labelling and Barcode Solutions, UK Afternoon coffee Implementing Bar Coding ­ Using GS1 Standards · Benefits of implementing bar coding · What bar code symbologies are available (e.g. linear 2D)? · Assessing the possibilities of 2D barcodes · Are the 2D barcodes going to be acceptable worldwide? When will the equipment be in place in all countries to read 2D barcodes? · Benefit of incorporating variable information into the bar code Janice Kite, Traceability Director Healthcare, GS1 Global Office, Belgium End of Session Question and Answers

Achieving Regulatory Compliance

09.10 Assessing New Issues Introduced by the Revision to the Medical Device Directive 2007/47/EC · Introduction to the new requirements introduced by the amending directive 2007/47/EC · Focusing on issues still under discussion among manufacturers, notified bodies and the EU commission · Assessing clear and unclear requirements Francesco Laterza, Director, Quality Assurance & Regulatory, CID Srl (Carbostent & Implantable Devices), former Vascular Therapy BU of Sorin Group, Italy New Labelling Requirements for Medical Devices · What is considered as labelling? · Identify the amendments of the medical device directive that have an impact on the labelling requirements · Provide an overview of the new requirements concerning labelling of single use devices, phthalates containing devices, dual CE marking · Review of some clarifications of borderline products by the EU commission · Adjacent regulations and their impact on the labelling of medical devices Holger Most, Regulatory Affairs EMEA, Kimberly-Clark Healthcare, The Netherlands Morning tea and coffee Labelling Requirements for Single Use Devices · Definition of single use devices · Reuse warning statement requirement per Revision 2007/47/EC · EUCOMED guidance on a risk based approach to establish the warning statement · Impact for global labelling strategies Peter Schroeer, Director Europe, Quality Systems & Regulatory Affairs, Johnson & Johnson, Germany Understanding the Impact of the REACH and CLP / GHS Legislation on Labelling for Medical Devices and IVDs · REACH requirements applicable to labelling of medical devices containing substances or preparations ­ safety data sheets · Impact of REACH on medical devices containing svhc's (substances of very high concern) · Impact of EU CLP / GHS Legislation on classification, labelling and packaging of substances and mixtures Ben Jacoby, Manager, European Regulatory Affairs, OrthoClinical Diagnostics, Johnson & Johnson, UK End of Session Question and Answers

09.50

14.50 15.20

10.30 11.00

16.00

11.40

Assessing the Possibilities of Electronic IFU Delivery and Alternative Means

16.15 EU Regulations for Electronic IFUs ­ The Current State Of Play · Assessing the expected key requirements · Structuring an EU road map to electronic IFUs Joachim Wilke, Director, Medtronic GmbH, Germany Closing remarks from the Chair End of Day 1

16.55 17.00

12.20

To Register Please Tel: +44 (0) 20 7017 7481 Email: [email protected]

Fax: +44 (0) 20 7017 7823 Web: www.informa-ls.com/labelling Please quote CQ7062

"I would recommend this conference to anyone that wants a better understanding of global labelling," (WL Gore & Associates Inc., 2008 Delegate) Day Two ­ Wednesday 28 October 2009

08.30 09.00 09.10 Registration Opening remarks from the Chair An Update on Instructions for Use (IFU) by Alternative Means · IFU by alternative means: internet, fax on demand, e-labelling, CDs ­ more cost effective and environmentally friendly · Are these widely used at the moment or are these new advances? · An update on any pilot studies rolled out ­ providing CD in lieu of a paper leaflet · Response from the regulators / notified bodies · Outlining the main implementation strategies and challenges (based on experiences with IVD) · Lessons learnt from the IVD industry Ian Hooper, Director, Ortho-Clinical Diagnostics, Johnson & Johnson, UK First Experiences with Electronic IFU Please visit www.informa-ls.com/labelling for further details Karin Listringhaus, Manager Regulatory Affairs, Roche Diagnostics Ltd., Switzerland Morning tea and coffee Advantages of using symbols Advantages and disadvantages of developing your own symbols ­ Symbols for labelling of phthalate content · Labelling for devices containing specific phthalates · Use of new symbols · What additional text is required in the IFU? Jim Willmott, Global Labelling Manager, Smiths Medical, UK 14.20 Spotlight Session Hosted by a leading company operating in the field of medical devices, this presentation slot offers an opportunity for delegates to learn about your product and/or services. If you would like to host a spotlight session, please contact: Linda Cole, Business Development Manager, Informa Life Sciences Tel: +44 (0)20 7017 6631 Email: [email protected] End of Session Question and Answers Afternoon tea ­ ­

14.50 10.00 15.05

Labelling Requirements in Developing Markets

15.35 Assessing the National Requirements for Labelling and Packaging in Emerging Markets · Updates on new regulations · Over label activity for emerging markets (China, Korea, Brazil, Russia etc) · Specific requirements in emerging markets (technical responsible person, import license number etc) · How to avoid translation of detailed label content Toni Kennet Joergensen, Vice President Corporate Regulatory Affairs, Straumann AG, Switzerland Assessing the National Requirements for Packaging and Labelling in Turkey · Updates on new regulations · The development of Turkey's own symbols · Specific labelling requirements for customs · Local (non-standard) UDI requirements Roland Back, Director of Regulatory Affairs & Quality Assurance, Bard Europe, UK End of Session Question and Answers End of Conference

10.40

The Use of Symbols to Overcome Language Issues

11.10 Successfully Overcoming Language and Translation Issues · Dealing with the increasing language requirements: 23+ in the EU · Managing the translation process · Assessing cost implications Alois Jochum, Head of Labelling Translations & Technical Support, Roche Diagnostics GmbH, Germany 16.15 11.50 The Importance of Symbols for Labelling IVDs · What the directives require on the use of symbols · What the standards (EN980 and ISO15223) require on the use of symbols · What's new with symbols? · The advantages and pitfalls of using symbols Richard J Saunders, Regulatory Affairs Manager EMEA, Abbott Diabetes Care Limited, UK 16.55 12.30 13.40 Lunch 17.10 Examining the Importance of the Use of Symbols for Labelling Medical Devices · Update on the guidelines for symbols · What new symbols, or changes to symbols are expected (EN 980 & ISO 15223-1)

Due to unforeseen circumstances, the programme may change and Informa reserves the right to alter the venue and/or speakers © Copyright Informa BV, 2009

CALL FOR SPONSORSHIP AND EXHIBITORS ­ 1 Exhibition · 2 Conferences · 1 Location!

Benefit from this exclusive opportunity to access key decision makers involved in labelling and packaging across the pharmaceutical, medical devices and IVD industries from 2 co-located conferences in one exhibition hall. Labelling and Packaging Compliance for Medical Devices and IVDs ­ www.informa-ls.com/labelling Pharmaceutical Labelling and Packaging Summit ­ www.informa-ls.com/pharmalabelling Raise your corporate profile by sponsoring or exhibiting at this event. This is a great opportunity to reach a carefully targeted audience. Make use of our excellent promotional and exhibition opportunities. By becoming an event partner you can: · Forge new alliances and joint ventures · Raise your profile and corporate image · Develop new client relationships and affirm existing ones · Launch new products and promote existing ones We have a wide-range of tailored sponsorship solutions, including conference sponsor, networking reception, spotlight sessions and exhibition stands ­ to find out more, please contact: Linda Cole, Business Development Manager, Informa Life Sciences Tel: +44 (0)20 7017 6631 Email: [email protected]

By attending this course, not only will you gain fundamental knowledge to work in the industry, but you will also gain formal recognition for your training via the CPD Certification Program. To find out more about CPD and the CPD Certification Service call Tel. +44 (0) 20 8840 4383 or email [email protected] You might also take a look at www.cpduk.co.uk

To Register Please Tel: +44 (0) 20 7017 7481 Email: [email protected]

Fax: +44 (0) 20 7017 7823 Web: www.informa-ls.com/labelling Please quote CQ7062

3rd Annual: Labelling and Packaging Compliance for Medical Devices and IVDs

27 ­ 28 October 2009 ­ Hilton Olympia, London, UK

www.informa-ls.com/labelling

Conference code: Workshop code:

CQ7062C CQ7062X

5 Easy ways to Register

LS/AAJ/SH/CC/DH

+44 (0)20 7017 7481 +44 (0)20 7017 7823 [email protected] www.informa-ls.com/labelling The Bookings Department Informa UK Ltd PO Box 406 Byfleet KT14 6WL

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Tel: +44 (0) 207 017 7077 or Fax +44 (0) 207 017 7828

Event selection Conference and Pre-Conference Workshop Conference Only Code CQ7062CX CQ7062C Date 26-28 Oct 2009 27-28 Oct 2009 Book before Friday 7 August 2009 £1898 + VAT @ 15% = £2182.70 £1199 + VAT @ 15% = £1378.85 Save £200 £200 Book between 7 August Save & Friday 25 September 2009 £1998 + VAT @ 15% = £2297.70 £1299 + VAT @ 15% = £1493.85 £100 £100 Book after Friday 25 September 2009 £2098 + VAT @ 15% = £2412.70 £1399 + VAT @ 15% = £1608.85

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Terms and Conditions

FEE: This includes all technical sessions, lunch and documentation in electronic format. CANCELLATIONS: Cancellations received in writing before and on Monday 12 October 2009 will be subject to a service charge of £99. The full conference fees remain payable after Monday 12 October 2009. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organiser to alter the content and timing of the programme or the identity of the speakers. In the unfortunate event that an event is cancelled Informa are not liable for any costs incurred by delegates in connection with their attendance. This contract is subject to English Law. ARE YOU REGISTERED?: You will always receive an acknowledgement of your booking. If you do not receive anything, please call us on +44 (0) 207 017 7481 to make sure we have received your booking. ANY SPECIAL REQUIREMENTS: Please inform us if you have any special requirements by calling Customer Services. +44 (0) 20 7017 7481

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Venue Details: Hilton London Olympia 380 Kensington High Street London, W14 8NL T: +44 (0) 207 856 1905 F: +44 (0) 207 602 5469 W: www.hilton.co.uk/olympia Reduced Rate Hotel Accommodation: The cost of the accommodation is not included in the conference fee. Reduced rate accommodation can be arranged for you as a free service to Informa Life Sciences delegates by contacting Zibrant on Tel: +44 (0)1332 285 590; email at [email protected] or web: www.zibrant.co.uk/informa Conference Documentation: Cannot Attend? For those busy executives who cannot take full advantage of this event, the papers give you a useful record of the presentations made at the event. The set of speakers papers and/or slides from the conference is available after the event for £399 + 15% VAT. Contact Customer Services on tel: +44 (0) 20 7017 7481, fax: +44 (0) 20 7017 7823 or e-mail: [email protected]

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