P 056 Pre Filled Syringes


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SMi present Europe\'s leading Pre-Filled Syringes conference, taking place in London in 28th-29th January 2013

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P 056 Pre Filled Syringes

  1. 1. "Brilliant. Complicated technology explained well”Teva Pharmaceuticals SMi PRESENTS THE 5TH ANNUAL Early Discounts Bird EUROPEAN :B SEPTEM OOK BY BER 28T SAVE £30 H 0 BOOK B OCTOBER Y 31ST SAVE £10 PRE-FILLED SYRINGES 0 EUROPES LEADING PRE-FILLED SYRINGES EVENT28TH - 29TH JANUARY 2013 | COPTHORNE TARA HOTEL, LONDON, UKKEY SPEAKERS INCLUDE: KEY REASONS TO ATTEND:• Advait Badkar, Associate Research Fellow, Explore the challenges for the development of HCLF biologics with Pfizer key industry professionals• Karoline Bechtold-Peters, Head, Clinical Consider the effects of leachables and extractables and evaluating Manufacturing, Roche interactions between formulation and containers• Patrick Garidel, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim Develop your understanding of regulatory compliance from• Carston Worsoe, Principal Scientist, Novo pharmaceutical companies and the MHRA Nordisk Hear from leading healthcare professionals on the growing use of• Jasdeep Singh, Head of Pharmacy pre-filled syringes at the patient ‘front line’ Manufacturing, Royal London Hospital• Richard Hart, Pharma Partner Executive, Streamline the filling and closing process by exploring facility design Baxter Healthcare strategies and syringe development line techniques• Violeta Gabrijelcic, Head Global Discuss the latest in vendor procurement and outsourcing strategies Pharmaceutical and Device Development, Sandoz Network with and learn from key industry professionals, leading• Morag Bratby, Pharmaceutical Assessor, academics and healthcare representatives MHRA PLUS TWO INTERACTIVE POST CONFERENCE WORKSHOPS Workshop A: The Future of Self-injection: Workshop B: Safety Issues Where do we want to be? within Pre-filled Syringes 8.30am - 12.30pm 1.30pm - 5.30pm 30th January 2013, Copthorne Tara Hotel, London, UK 30th January 2013, Copthorne Tara Hotel, London, UK Workshop Leaders: Martin Bontoft, Head of Design Workshop Leaders: Research and Julian Dixon, Director of Human Factors, Simon Cohen, Director, Innovate UK Team Consulting NEW FOR 2013: EVENING DINNER AT THE GILGAMESH RESTAURANT Sponsored by www.pre-filled-syringes.com Register online or alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
  2. 2. DAY ONE | MONDAY 28TH JANUARY 2013 Very informative with a great mix of speakers“ Sanofi-Aventis 8.30 REGISTRATION & COFFEE 14.10 Q & A Discussion with the Morning Session Speakers 9.00 Chairmans opening remarks 14.30 AFTERNOON TEA Advait Badkar, Associate Research Fellow, Pfizer PRIMARY PACKAGING DEVELOPMENTS PRE-FILLED SYRINGE FORMULATIONS 14.50 Daikyo Crystal Zenith® Prefillable 9.10 Development Considerations for Biologics as Pre-Filled syringe Systems: A Superior Containment Syringe Products: A QbD approach Alternative over Glass Syringes • Quality Attributes for Pre-filled syringe products that are • The unique properties of Daikyo Crystal of concern Zentih prefillable syringe systems • Component Selection and Risk Assessment • Discussion into the associated processing requirements • Co-development with Component Manufacture to fill and finish these unique systems • Taking these lessons and making immediate • Exponential advantages for the safety and stability of high improvements value biopharmaceutical drug products Advait Badkar, Associate Research Fellow, Pfizer Nicolas Brandes, Director Strategic Marketing Daikyo Crystal Zenith Products, West Pharma 9.50 PFS Developments for Biotechs • Prefilled syringe market overview 15.30 Interactions between formulation components and container • Patient, regulatory and operational • Reducing extractables and leachables in pre-filled syringes excellence trends for the biotech by collaborations with packaging design • Injectable market • Interactions with primary packaging • Development of new biotech prefillable systems answering • Techniques for inspection unmet needs • Differences between interactions in glass and plastic Nicolas Morais, Product Manager, Europe, Prefillable syringes Syringes, BD Medical Sandipan Sinha, Prinicpal Scientist, Pfizer 10.30 MORNING COFFEE 16.00 Proven Glass Coding Technology allows for full Traceability in Production and the 11.00 Extractables and Leachable investigations and Supply Chain documentation for pre-filled syringes • Total visibility of the manufacturing process • Risk assessment for extractables and leachabes in PFS through batch record/ pedigree on item level • Optimal study for PFS - extractable, simulated or leachable • Preventing of mix-ups between production lots even of study ? unlabeled containers • Experiences with glass vs. plastic PFS • Method to support filling lines clearing after product change • Case studies on extractables and leachables in PFS systems • Identifying a single item in the after sales supply chain to Carsten Worsoe, Principal Scientist, Novo Nordisk authenticate its original provenance to fight against product piracy. 11.40 Development of pre-filled syringes for high concentrated Carmen Heiter, Product Management, Syringes, Schott liquid protein formulations • Challenges for the development of HCLF biologics 16.40 Primary container developments; Glass V Plastic • Interactions with primary packaging • Developments in glass syringes; stability and permeability • Stability issues • Advanced processing and inspections of glass containers • New manufacturing techniques of polymer based containers • Medical requirements and application • Filling capability of polymer syringes Patrick Garidel, Associate Director Protein Science, Moderator: Boehringer Ingelheim Martin Bontoft, Head of Design Research, Team Consulting 12.20 NETWORKING LUNCH Panelist: Patrick Garidel, Associate Director Protein Science, 13.40 Leachables and Extractables in Pre-Filled Syringes Boehringer Ingelheim and Advait Badkar, Associate Research • Review of current guidance available Fellow, Pfizer • Reducing, monitoring and controlling interactions • Non-invasive methods of detection 17.10 Chairman’s Closing Remarks • Effects of material selections • Performing controlled extraction studies 19.00 Evening Reception and Dinner All attendees and speakers are invited Stephen Barat, Senior Director, Toxicology and Operations, to join us for a formal dinner. Transport Forest Laboratories will be provided at 19.00 from the conference hotel New for 2013: Evening Dinner at the Gilgamesh Restaurant SMi Group invites you to join them for a post conference dinner reception following the end of the first day. Dinner will be held at Gilgamesh Restaurant and Bar where you will have the extended opportunity to network with industry professionals. Jump aboard a traditional red london bus at the hotel at 7.00pm for a real London experience. Leave Pre-Filled Syringes 2013 having forged new working relationships and strengthened your current ones. The Gilgamesh Restaurant and Bar combines history with elements of contempory design and modern art to make one of the most visually stunning venues in central London. In the Babylon Bar you will experience some of the finest pan-Asian cuisine prepared by award winning chefs. Dine, drink and socialize in jaw dropping surrounds. A truly unforgettable experience. Register online at www.pre-filled-syringes.com • Alternatively fa
  3. 3. "Very interesting perspectives on PFS changes” Abbott 8.30 REGISTRATION & COFFEE 14.30 Safety Devices for Self-injection Drugs DAY TWO | TUESDAY 29TH JANUARY 2013 • Safety devices as a primary choice 9.00 Chairman’s Opening Remarks to be added to pre-filled syringes to Patrick Garidel, Associate Director Protein Science, Boehringer Ingelheim meet anit-needlestick legislation around the globe FILLING, FINISHING & FACILITY DESIGN • Currently a growing number of biotech drugs in pharma’s pipeline that require self-injection device to satisfy patients’ 9.10 Challenges and solutions in fill and finishing lines • The importance of flexibility in filling operations needs and handle new drug properties eg. Higher viscosities • Potential strategies to reduce costs and speed up processes • How was the design of a clinically proven safety device • Dual-chamber syringes adapted to meet those new requirements • Meeting deadline, budget and quality requirements Tobias Posset, Head of Production Support, Roche Alexander Jaksch, VP of Business Development and Marketing, Safety Syringes, Inc 9.40 Secondary Packaging; Hero or villain of the PFS world? An overview to PFS Secondary 15.10 Reducing contamination and medical Packaging machinery errors with PFS in the acute care • Relationship to filling lines environment and address the need for • Current status of secondary packaging machinery compatibility with syringe pumps • Current issues for the handling of filled syringes • BD response: New generation of polymer large size PFS • Relationship to tertiary packaging • Presentation of the solution: superior Materials (CCP Dale Charlton, Business Development Director, Optima &rubber), innovation with patented luer lock 10.20 MORNING COFFEE • Seamless transition by design: acceptance in syringe pumps • Technical performance and pumps requirements: tests on 10.50 Validation and Qualification of a cRABS Clinical Supplies Line gliding, clinical study on product performance • Review of restricted access barrier systems • Obtaining a higher level of assurance for aseptic filling • Human Factors: Preliminary results of the clinical study on compared to cleanroom processes user acceptance figures and product preference • Industrial scale production lines • Platform for new generation of plastic products at BD, for • Combination filling stations Karoline Bechtold-Peters, Head, Clinical Manufacturing, Roche applications in other therapeutical classes Dragana Cvijanovic, Product Manager, BD Medical 11.20 Silicone layer control thickness and protein aggregation in prefilled syringes 15.50 AFTERNOON TEA • Linking the influence of siliconisation parameters and the silicone agglomeration REGULATORY & COMMERCIALISATION TRENDS behaviour of the protein based drug • Enabling the understanding of the siliconization process in 16.10 Regulatory Aspects of Pre filled Syringes in Europe order to minimize silicone induced issues for development • Pre-filled syringe: medicinal product or medical device and manufacturing • Borderline Examples • Considering issues related to the interaction of silicone oil • Auto-injectors and protein based formulations • Investigating these interactions by image directed particle • Module 3: Quality - including special focus on the Raman spectroscopic analysis equipment (SPE) Manufacturing Process, Container Closure aspects Oliver Valet, Managing Director, rap.ID GmbH • Agency feedback: Licensing • the Regulatory Horizon 12.00 Q & A Discussion with Filling and Finishing Session Speakers • Future MAA trends: Rapid Micro Methods 12.20 NETWORKING LUNCH Morag Bratby, Pharmaceutical Assessor, MHRA DEVICE DESIGN AND PATIENT SAFETY APPROACHES 16.40 Pre-filled Syringes: An NHS Perspective • Manufacturing of pre-filled syringes as ‘specials’ 13.30 Formulation and Pre-filled Syringe Development for • Problems at the coal face – how can we overcome then? Biosimilars - Sandoz Experience • Patient perspectives • What are the common obstacles in development? • Specifics in biosimilar syringe development • Lessons pharma can learn from the NHS • Focus on Sandoz Case Studies Jasdeep Singh, Head of Pharmacy Manufacturing, Royal Violeta Gabrijelcic, Head Global Pharmaceutical and Device London Hospital Development, Sandoz 17.10 Manufacturing pre-filled syringes with a contract 14.00 The role of pre-filled syringes in patient safety manufacturing partner. • Current trends in parenteral therapy • Finding and selecting a partner • Intravenous medication safety • New international recommendations and regulations • Contracting for success • Overcoming challenges • Advantages of pre-filled syringes • Achieving excellent outcomes • Barriers to the introduction of pre-filled syringes Richard Hart, Pharma Partner Executive, Baxter Healthcare David Whitaker, Consultant Anaesthetist, Manchester Royal Infirmary 17.40 Chairman’s Closing Remarks and End of Day Two Official Media Partner Supported by Want to know how to get involved? Interested in promoting your services to this market? Contact Margaret Mugema on +44 (0) 207 827 6072 or email: mmugema@smi-online.co.ukax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
  4. 4. PLUS TWO INTERACTIVE POST–CONFERENCE WORKSHOPSWEDNESDAY 30TH JANUARY 2013, COPTHORNE TARA HOTEL, LONDON, UKWorkshop A: Workshop B:The Future of Self-injection: Safety Issues withinWhere do we want to be? Pre-filled Syringes Innovate UK8.30am - 12.30pm 1.30pm - 5.30pmWorkshop Leader: Martin Bontoft, Head of Design Research Workshop Leader: Simon Cohen, Director, Innovate UKand Julian Dixon, Director of Human Factors, Team ConsultingOverview OverviewWe have seen an explosion of attention to human factors (HF) in This unique masterclass will focus on the latest developments indrug delivery device development. This has been the era of patient safety in Pre-Filled Syringe development and will provideusability, marked by a focus on the effectiveness and safety of an insight into alternative forms of risk. Led by the expertise anddevices in the hands of users. By focusing on case studies from experience of Simon Cohen, Director at Innovate UK thisadjacent fields, this interactive workshop will discuss and workshop will present attendees with an in-depth view into theshowcase the new methods and mindset that need to adopted in risks associated with Pre-Filled Syringes and evaluating needleorder to meet our ambitions for self-injection. stick injury and splash risk.Timetable Timetable8.30 Registration & Coffee 13.30 Registration & Coffee9.00 Welcome & Introductions 14.00 Welcome & Introductions9.15 The landscape and current trends in self-injection 14.10 Overview into Needle Stick Injury Risk • Current needle safety devices that are available9.45 How to ‘do’ human factors engineering in line with • Comparing Automated and Table-Top Devices regulatory requirements 14.45 Evaluating alternative forms of risk10.15 Beyond validation: desirability, advocacy, adherence • Case Study Focus Session10.45 Mindsets and methodologies for researching the 15.45 Afternoon Tea patient experience 16.00 Investigation into Splatter Risk for Pre-Filled Syringes11.15 Morning Coffee • Developing splatter trials • Discussing Chemical and Cross-Infection Hazards11.30 The customer journey: the path to participation 17.00 Discussion Session12.00 What constraints have we imposed on our user appeal 17.30 Close of Workshop aspirations by the technology we’ve selected?12.30 End of Workshop About Simon Cohen, Director, Innovate UK Simon has worked both in the NHS and private practice specialising in the prevention and treatment of sports injuryAbout Team Consulting: through gait analysis and biomechanics. He joined PfizerWe are recognised globally as experts in the design and working as an NHS liaison specialist before continuing hisdevelopment of medical devices. That’s all we do and we are career in The Pharmaceutical Sector in various sales, marketing and NHS liaison roles. Simon is one of the founders of Innovateproud of this focus. It enables us to deliver real insight and UK Ltd, alongside a number of working Doctors and anexpertise to our clients.Commercially successful products need international lawyer. The aim for the company is to provide ato be safe, easy to use and ultimately make people better. Our service to both The Pharmaceutical Industry and the NHS inclients like our approach, which combines design, human quick turn round innovative device solutions. Their ability to turnfactors, science and engineering from inspiration right through a basic idea into a finished prototype within a two-week periodto industrialisation. has won them a number of key customers within the sector, and has continued to grow their portfolio of innovative solutions. In particular, within the safety market, in this field. Simon has also worked as a support for lobby groups within The European Parliament. New for 2012: SMi Event Communities SMi Group is a global events business specialising in business to share, engage and network. The SMi Event Communities will business conferences, workshops and masterclasses. build and expand your experience beyond the conference, workshop or Masterclass you attend. Not just another "social We successfully create and run 250 events every year across 6 network”, SMi’s Event Communities have been specifically sectors including Defence and Security, Energy and Utilities, designed around the needs of our delegates, speakers and Finance and Pharmaceuticals. We believe in bringing together sponsors, allowing all of our clients to foster longer term the most knowledgeable experts from across the globe in each relationships with all of the other attendees beyond the three sector to learn, engage, share and network be it in London, day event for year round engagement. Paris or Singapore. To take part all you need to do is register for this event. To further enhance the SMi experience, we have launched our very own SMi Event Communities. These will be exclusive, SMi Group Communities private and secure communities in which our clients will learn, Learn Engage Share Network
  5. 5. European Pre-Filled Syringes 2013 Sponsors BD Medical Pharmaceutical Systems is a worldwide leader in supplying the pharmaceutical industry with quality drug delivery systems and safety-engineered devices. Our cutting-edge delivery systems are customizable to meet patient needs, are market tested and are manufactured to meet the high quality standards that our customers expect. BD Medical - Pharmaceutical Systems provides a comprehensive range of prefillable injection systems using clinically proven products that help deliver enhanced drug or end-user benefits and results, and access to information and distribution networks worldwide. For years we have also been one of the most active promoters of healthcare worker safety. www.bd.com OPTIMA pharma with the long established brands of inova, Kugler, Klee and Metall + Plastic isolation technology offer a comprehensive, cutting-edge range of products and services in pharmaceutical fill / finish. This includes the filling and packaging of pharmaceutical liquids and powders in syringes, vials, infusion bottles etc., as well as freeze drying systems and automatic loading / unloading systems. Turnkey production and packaging lines for medical / pharmaceutical products and project management of such complex projects complete with global production / service capabilities compliments the portfolio and offering from OPTIMA pharma. www.optima- pharma.com rap.ID provides compliant solutions for the control of silicone and other lubricants (i.e. thickness and distribution) in pre-filled syringes. rap.ID also offers services providing foreign particle identification. Latest invention is the SPE metal.ID+raman.ID. With this tool any user identifies foreign particulate matter with a unique speed and high power of recognition. www.rap-id.com Safety Syringes, Inc. (SSI) has established itself as the market leader in safety devices for prefilled glass syringes and the preferred partner of the world’s leading pharmaceutical companies. With a strong core competency in needlestick safety devices for prefilled glass syringes, SSI will continue to lead the expanding prefilled syringe market with solutions that reduce the costs of meeting increasingly stringent anti-needlestick legislation. www.safetysyringes.com SCHOTT Pharmaceutical Systems is one of the world’s leading suppliers of glass tubing and primary packaging for the pharmaceutical industry. We provide our customers quality solutions while meeting their highest demands with our material expertise, specialized analytical lab services, and a broad product portfolio; including, syringes, cartridges, vials, ampoules, and special articles made of glass and COC polymer. With four glass tubing production sites and seventeen sites for pharmaceutical packaging spread over four continents, we offer safe supply and local service. Our state-of-the-art production facilities and our products comply with the highest international quality standards for pharmaceutical needs. www.schott.com West Pharmaceutical Services is a global leader in providing solutions for injectable drug administration. The products West makes and the services the company provides help improve health care for people around the globe.West’s innovative system, device and component solutions help improve the safety and administration of injectable drugs. West’s proprietary materials science, formulation research and manufacturing technologies advance the quality, therapeutic value, development speed and rapid market availability of pharmaceuticals, biologics and vaccines. West’s customers include the world’s leading pharmaceutical, biopharmaceutical and medical device companies. West supports its customers with sales, manufacturing, customer support and research and development from 50 locations in North and South America, Europe, Asia and Australia. www.westpharma.com SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your companys marketing strategy. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick, SMi Sponsorship on +44 (0)20 7827 6168 or email: amalick@smi-online.co.uk www.pre-filled-syringes.comFAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South,PHONE on +44 (0) 870 9090 711 Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
  6. 6. EUROPEAN PRE-FILLED SYRINGESMONDAY 28TH & TUESDAY 29TH JANUARY 2013, COPTHORNE TARA HOTEL, LONDON, UK WORKSHOPS: WEDNESDAY 30TH JANUARY, 2013, LONDON 4 WAYS TO REGISTER www.pre-filled-syringes.comFAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South,PHONE on +44 (0) 870 9090 711 Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK EARLY BIRD □ Book by 28th September 2012 to receive a £300 off the conference price DISCOUNT □ Book by 31st October 2012 to receive a £100 off the conference price CONFERENCE PRICES I would like to attend: (Please tick as appropriate) Fee Total □ Conference & 2 Workshops: £2797.00 + VAT £3356.40 □ Conference & 1 Workshop: £2198.00 + VAT £2637.60 □ Conference Only: £1599.00 + VAT £1918.80 □ 1 Workshop Only: £599.00 + VAT £718.80 □ 2 Workshops Only: £1198.00 + VAT £1437.60Unique Reference Number Workshop A □ Workshop B □ First 25 Pharmaceutical CompaniesOur Reference LVP-056 □ Conference + 2 Workshops: £2097.00 + VAT £2516.40 □ Conference + 1 Workshop: £1498.00 + VAT £1797.60 □ Conference Only: £899.00 + VAT £1078.80DELEGATE DETAILS Workshop A □ Workshop B □Please complete fully and clearly in capital letters. Please photocopy for additional delegates. REGISTRATION INCLUDES FREE ATTENDANCE AT (PLEASE TICK) □ End of Day 1 Evening Dinner at Gilgamesh Restaurant and Bar (28th January)Title: Forename: PROMOTIONAL LITERATURE DISTRIBUTIONSurname: □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80Job Title: GROUP DISCOUNTS AVAILABLEDepartment/Division: The conference fee includes refreshments, lunch, conference papers and access to the Document Portal containing all of the presentations.Company/Organisation:Email: VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London W8 5SRCompany VAT Number:Address: □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712Town/City:Post/Zip Code: Country: DOCUMENTATIONDirect Tel: Direct Fax: I cannot attend but would like to purchase access to the following DocumentMobile: Portal/paper copy documentation Price TotalSwitchboard: □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80Signature: Date: □ The Conference Presentations – paper copy £499.00 - £499.00I agree to be bound by SMis Terms and Conditions of Booking. 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Please indicate method of payment:Address (if different from above): □ UK BACS Sort Code 300009, Account 00936418 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AUTown/City: Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18Post/Zip Code: Country: □ Cheque We can only accept Sterling cheques drawn on a UK bank.Direct Tel: Direct Fax: □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges.Terms and Conditions of Booking Card No: □□□□ □□□□ □□□□ □□□□Payment: If payment is not made at the time of booking, then an invoice will be issued and must be Valid From □□/□□ Expiry Date □□/□□paid immediately and prior to the start of the event. If payment has not been received then credit card CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX carddetails will be requested and payment taken before entry to the event. Bookings within 7 days ofevent require payment on booking. Access to the Document Portal will not be given until paymenthas been received.Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another Cardholder’s Name:delegate to take your place at any time prior to the start of the event. Two or more delegates maynot ‘share’ a place at an event. Please make separate bookings for each delegate. Signature: Date:Cancellation: If you wish to cancel your attendance at an event and you are unable to send asubstitute, then we will refund/credit 50% of the due fee less a £50 administration charge, I agree to be bound by SMis Terms and Conditions of Booking.providing that cancellation is made in writing and received at least 28 days prior to the start of theevent. Regretfully cancellation after this time cannot be accepted. 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Unless you tick here □ we may also share your data with third parties VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on Documentoffering complementary products or services. If you have any queries or want to update any of thedata that we hold then please contact our Database Manager databasemanager@smi-online.co.uk Portal and Literature Distribution for all UK customers and for those EU customers not supplyingor visit our website www.smi-online.co.uk/updates quoting the URN as detailed above youraddress on the attached letter. a registration number for their own country here: ______________________________________ If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk