P 012 Cold Chain Distribution

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SMi proudly presents its 6th annual Cold Chain Distribution conference to be held in London on Monday 5th & Tuesday 6th of December 2011. This conference follows on from SMi’s previous highly successful Cold Chain Distribution events and offers the opportunity to keep up-to-date with the latest regulations, challenges and solutions that you need to know about for successful and cost-effective cold chain distribution

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P 012 Cold Chain Distribution

  1. 1. REGISTER BY 30TH SEPTEMBER 2011 AND RECEIVE A £100 DISCOUNT EUROPE’S LEADING COLD CHAIN CONFERENCE SMi present their 6th annual conference on… Cold Chain Distribution & New For 2011: Temperature Control Management Monday 5th & Tuesday 6th December 2011 Marriott Regents Park, London KEY SPEAKERS SO FAR INCLUDE: Ray Goff Nigel Cryer Director Head Quality Operations Pfizer Arrow Pharrm Marc Mostinckx Gerald Cavalier Senior Director, Global Logistics Lead Executive Director UCB Cemafroid Elvia Quiroz Loriega Andrea Graf-Gruber Cold Chain & Shipping Validation Specialist Manager, Cargo Business Process and Pfizer Standards International Air Transport Association Stephen Mitchell QA Manager, Quality & Compliance, Sue Lee Logistics Regional Quality Manager, UK & Ireland GSK World Courier WHY ATTEND THIS EVENT: • Analyse the environmental impact and responsibilities within the cold chain. Reusable and recyclable packaging will play an ever more important role to maintain green credentials, but are they cost effective? • Develop your understanding of data management within your cold chain • Understand new regulations - learn how to adapt to new CRT regulations. Gain advantage and avoid costly & time consuming auditing • Explore the possibility of an uninterrupted cold chain - with supply delays causing massive disruption as well as coming at a heavy cost it is more important than ever to effectively contingency plan. Minimising and avoiding delay is critical within the cold chain • Improve your monitoring of wholesaler security. Passing trust and liability on comes with risk but also reward for both parties. Effective management of the relationship is therefore critical • Evolve your understanding of temperature control management. New temperature management regulations effect not just the cold chain, but also room temperature storage, as room temperature can fluctuate wildly and needs to be controlled and supervised correctly PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS Wednesday 7th December 2011, London Marriott Hotel Regents Park Workshop A: Practical Management of Risk Workshop B: A Measured Approach Towards in the Pharmaceutical Cold Chain Temperature Controlled Shipments Workshop Leader: Workshop leader: Jane Seeley, Managing Director, GeoStasis Ltd Robert J Hayes, Director, Cold Chain Consultants (UK) Ltd 1.30pm - 5.30pm 8.30am - 12.30pm Gold Sponsor Sponsored bywww.coldchain-distribution.comRegister online and receive full information on all of SMi’s conferencesAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
  2. 2. Cold Chain DistributionDay One | Monday 5th December 2011 www.coldchain-d8.30 Registration and Coffee Cold Chain Planning9.00 Chairmans opening remarks 2.10 Putting a global organization in place to deal with Distribution, Cold Sue Lee, Regional Quality Manager, UK & Ireland, World Courier Chain Management and Shipping Qualification for new products • Understanding the key considerations when creating a fit-for-9.10 Offsetting fuel costs in clinical distribution purpose logistics department • Outline of current systems used • Identifying, training and organizing an effective global logistics team • 7-8 new ways to offset fuel price increases • Assuring optimal management of shipping solution validation • Modelling your response to price increases • Exploring the UCB cold-chain logistical setup and lessons learned in Ray Goff, Director Vaccine Research, Pfizer the management of a global cold-chain system • Examining the methods, procedures and solutions used in the9.50 When to and why use a specialist courier? transportation of temperature sensitive shipments and the rationale of the choices made A conversation between Finance and Quality to make the best Marc Mostinckx, Senior Director, Global Logistics Lead, UCB decisions about using a clinical trials transport budget This will consider what to take into account for: 2.50 Data Management in Cold Chain • Difficult and Emerging Markets • Why is it important to collect and manage the temperature data • Temperature Controlled Shipments coming from cold chain monitoring? • Controlled Drugs • What are the challenges with data management in Cold Chain? • Biologics and Biomarkers • What are the solution approaches and what are the advantages and Sue Lee, Regional Quality Manager, UK & Ireland, World Courier disadvantages of the different approaches? • "Big Pharma best practice example": Monitoring and data10.30 Morning Coffee management process in a complex supply chain Martin Peter, Director, Elpro-Buchs AG Temperature Control Analysis 3.30 Afternoon Tea11.00 Pharmaceuticals cold chain guidelines update • International transport under controlled temperature for 4.00 Panel Discussion: Emerging regulatory temperature monitoring pharmaceuticals requirements for non cold chain products • Last km of pharmaceuticals cold chain • Discussion on regulatory expectations • Certification initiatives and frames for pharmaceuticals cold chain - Which regulators are active in this area? • Sustainability of pharmaceuticals cold chain - What is in / out of scope? • Approaches to managing the requirements Gérald Cavalier, Executive Director, Cemafroid • What to do with data that has not been collected before & dealing with ‘excursions’11.40 Predictive risk-based supply modelling in clinical trials Panel Chair: Stephen Mitchell, QA Manager, Quality & Compliance, • Main uncertainties and risks in CT supply chain process Logistics, GlaxoSmithKline • Predictive patient recruitment modelling tool • Risk-based supply predictive modelling 5.00 Chairmans Closing Remarks • Software tools for supply modelling Prof. Dr. Vladimir Anisimov, Senior Director, Quantitative Sciences, 5.10 Drinks Reception GlaxoSmithKline - UK - Hosted by12.20 Networking Lunch Please join us for a drinks reception immediately after the panel discussion which closes the first day. This1.30 Cold Chain Distribution in Clinical Home Care will be a relaxed and social setting for you to network • Overview of clinical home care with delegates and sponsors and to follow up any • The scale of the cold chain distribution challenge questions you may have with speakers • Benefits to Pharma, patients & healthcare providers Kerry Hinton, General Manager, Healthcare At Home Ltd 6.40 Close of Day One Register online at www.coldchain-distribution.com • Alternatively f Who should attend? • Global Category Manager • Logistics Manager • Senior Transportation Manager • Principle Supply Chain Analyst • Logistics Manager CEE & Asia • QA Manager • Regulatory Affairs Manager • Clinical Supply Technician • GDP Inspector • Head of Service • Supply Chain Supervisor • Senior Director • Operations Director • MD • Cold Chain Specialist • Logistics manager • Business Development • Product Specialist • Shipping Specialist • Consultant - Supply Chain Manager • Pharmaceutical Warehouse • Cold Chain & Shipping • International Logistics Manager • Sr. Pharmaceutical Scientist Supervisor Validation Specialist Official Platinum Media Partners Supported by
  3. 3. Cold Chain Distributiondistribution.com Day Two | Tuesday 6th December 2011 8.30 Re-registration and Coffee Cold Chain Management 9.00 Chairmans opening remarks 1.50 Truck carrier selection and their qualification Tony Wright, Managing Director, Exelsius Cold Chain Management • Why is it so urgent? Transportation Planning • Making the right choice • Pharma requirements 9.10 Management of transportation of temperature sensitive goods • From Guidance to Regulation – how has this been achieved? • Current regulations • Importance of Standards – IATA development of a standard label Christoph Frick, PhD Head of Quality Assurance and Pharmaceutical • What are the challenges and how are these addressed? Development Qualified Person, Kohlpharma GmbH • The way forward and future requirements Andrea Graf-Gruber, Manager Business Process & Standards, IATA 2.30 Auditing Cold chain and temperature-sensitive supply chains 9.50 Passive Shipper Qualification – A bracketing Approach - A presentation on case studies from around the world. • Grouping similar lanes over a summer/winter period • Why temperature sensitive-supply chains fail a GDP audit • Bracketing multiple lanes for a single set of qualification data • Where they go wrong • Adding lanes without performing additional qualification • What to do when things go wrong (off-loads/delays) • Validating your supply chain • Quick, visual, determination of shipper performance within a lane • Challenges for the industry Royce Heap, Cold Chain Manager, Pfizer • A proactive approach Andrew Meyers, Managing Director, Cold Chain Consultants 10.30 Morning Coffee 11.00 When are transportation studies required and when not: 3.10 Afternoon Tea A Risk based approach • Is transportation the same as storeage? • Which products need are at risk and protection? 3.40 Maintaining data security throughout the distribution network • Which trade lanes, modes of transport are at risk? • Role of Standards • When do we need to do transportation studies? • Traceability in Healthcare Nigel Cryer, Head Quality Operations, Arrow Pharrma – Watson • Coding in Traceability Pharmaceutical Group • Implementing Traceability 11.40 Utilizing In-transit Temperature Monitoring to Improve the Quality and Roger Lamb, Healthcare Manager, GS1 UK Efficacy of Biopharmaceuticals: A Case Study • Why decreasing revenue streams and the growth of 4.20 Shipping container validation or qualification; semantics or is there biopharmaceuticals are driving optimized supply chains • How changes in healthcare delivery will affect the supply chain: a difference? chain-of-custody, the last mile and ensuring 100% efficacy • What is shipping container validation? • Temperature monitoring options for the supply chain: advantages and • What is shipping container qualification? disadvantages • Improving the supply chain: benefits for manufacturers, distributors, • Differences and similarities providers and the patient • Conclusion • Case study: Real-world use cases utilizing in-transit temperature Elvia Quiroz Loriega, Cold Chain & Shipping Validation Specialist, Pfizer monitoring SA de CV Peter Mehring, CEO, Intelleflex 12.20 Networking Lunch 5.00 Chairman’s Closing Remarks and Close of Day Twofax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 PHARMACEUTICAL FORWARD PLANNER SEPTEMBER Pharmaceutical mHealth European Pharmaceutical JANUARY Advances and Progress APRIL JULY Biomarkers in Clinical 10-11 October 2011 Pricing and Reimbursement Biomarkers Summit in Drug Design Asthma & COPD KOL Management and MSL Trials 31 October-1 November 16-17 January 2012 20-21 February 2012 16-17 April 2012 Best Practice in Europe 19-20 September 2011 GP Commissioning 2011 (Switzerland) 2-3 July 2012, 12-13 October 2011 Pre-Filled Syringes MARCH MAY (Switzerland) Biosimilars and Biobetters NOVEMBER 18-19 January 2012 Imaging in Cancer Drug “Generics, Supergenerics 26-27 September 2011 COPD: Novel Cell Based Assays Development and Patent Strategies” ADMET Therapeutics and 21-22 November 2011 Social media in the 5-6 March 2012 14-15 May 2012 9-10 July 2012 KOL Management Technology Trends pharma industry and MSL Best Practice 19-20 October 2011 Clinical Trials in CNS 23-24 January 2012 Superbugs & Superdrugs Clinical Trial Logistics Social Media in the 28-29 September 2011 23-24 November 2011 - A Focus on Antibacterials 16-17 May 2012 Pharmaceutical Industry Point of Care Diagnositcs - FEBRUARY 14-15 March 2012 Pain Therapeutics 9-10 July 2012 OCTOBER Market Opportunities and DECEMBER Parallel Trade 21-22 May 2012 Partnerships with CROs Technology Trends Cold Chain Distribution 6-7 February 2012 Controlled Release BioBanking 3-4 October 2011 24-25 October 2011 5-6 December 2011 28-29 March 2012 ADC Summit 2012 11-12 July 2012 23-24 May 2012 All conferences take place in central London, UK – unless indicated otherwise in brackets
  4. 4. HALF-DAY POST-CONFERENCE AM WORKSHOP8.30am – 12.30pm Wednesday 7th December 2011Workshop A: Practical Management of In association withRisk in the Pharmaceutical Cold ChainWorkshop Leader: Robert J Hayes, Director, Cold Chain Consultants (UK) Ltd Overview of workshop The workshop will review current and future regulatory trends in the application of risk-management Programme methodologies to the temperature-controlled pharmaceutical supply chain. It will take a practical 8.30 Registration & Coffee look at the tools and techniques for risk assessment and delegates will have the opportunity to work through real examples using an established industry model. Delegates will be helped to identify and 9.00 Welcome & Introductions develop solutions to common problems found in the pharmaceutical supply chain. 9.10 History of risk-based approach in the Why you should attend: pharmaceutical industry • Analyse future risk trends • Enjoy practical study of risk assessment • Share insight with experienced Cold Chain • Develop solutions to problems in the supply 9.50 Current and future trends specialists chain that your business faces • Regulator • Industry About the workshop host The workshop will be led by Eur Ing Robert J Hayes BSc, CEng, FIMechE, FIET 10.30 Morning Coffee Bob has worked in the Pharmaceutical Industry for thirty years. A Chartered Mechanical Engineer, his experience includes Production and Engineering Management, New Product Development, 11.00 Tools and techniques Factory Design, Supply Chain Management, Validation and a variety of support functions. Bob is Vice Chair of the Pharmaceuticals Technical Activity Committee of the Institution of Mechanical Engineers and a Fellow of the Institution. 11.30 Extended workshop – using FMEA Practical solutions to common problems About Cold Chain Consultants (UK) Ltd Cold Chain Consultants offers unique and specialist services focusing on the operational requirements 12.30 Close of Workshop of temperature sensitive supply chain. Cold Chain Consultants combine skills and experience in logistics, temperature measurement, qualification, mapping, cold chain packaging, refrigeration and GDP to provide invaluable cold chain knowledge. Cold Chain Consultants are specialists in cold chain and temperature sensitive logistics for the pharmaceutical, life sciences and blood product industries.HALF-DAY POST-CONFERENCE PM WORKSHOP1.30pm – 5.30pm Wednesday 7th December 2011Workshop B: A Measured Approach Towards In association withTemperature Controlled ShipmentsWorkshop Leader: Jane Seeley, Managing Director, GeoStasis Ltd Overview of workshop Programme The workshop will provide a high-impact, in-room business simulation to accelerate your awareness 1.30 Registration & Coffee and understanding of the Cold Chain. This interactive workshop reviews the challenges that exist as we explore the journey, the products and services that are on offer and benefits of a ’Service Management’ 2.00 Welcome & Introductions approach to temperature controlled shipments. Following this workshop you will have an appreciation of how to benchmark your supply chain in order to drive a continuous improvement culture. 2.10 Short overview and simulation ‘warm-up’ Why you should attend: 2.30 Facilitated simulation that will: • Learn more about service management in • Analyse your own solutions and findings and • Experience the supply chain in action the Cold Chain how they can be used in your business • Reflect on observations • Experience the Cold Chain in action in an • Increase your awareness and understanding • Draw upon conclusions & learning’s interactive business simulation of the Cold Chain • Put these learning’s into practice About the workshop host 3.30 Afternoon Coffee Jane Seeley has over 28 years’ experience of delivering international best practice and Innovative solutions in support of supply chain excellence. Having worked for one of the world’s largest logistics 4.00 Simulation session completion companies, responsible for strategic direction, development and delivery of innovative solutions, Jane has a comprehensive understanding of the international challenges that exist, the components required 4.30 Workshop conclusions on how to make and the alignment of multiple service partners that is critical to prove a true end to end service. This a step change towards a measured understanding along with the vision and passion to mature the management of perishable cargo drove approach to temperature controlled Jane to co-found GeoStasis Ltd. shipments. About GeoStasis Ltd 5.30 Close of Workshop GeoStasis Ltd brings together best of breed products and services to focus on the provision of quality logistics solutions with special attention to performance based operating processes.
  5. 5. Gold Sponsor As cold chain shipments excursions face increased scrutiny from regulators around the world, it is more important than ever before to get it right the first time. World Courier is the sole truly global premium logistics provider to offer a cold chain transport service. We lend intangible regulatory insight, unmatchedexperience and value-added support worldwide, including emerging markets such as Brazil, India, Argentina and Russia.Service Features• Comprehensive Guidance with Country Specific Import Requirements• Global SOP’s for All Temperature Ranges• Consultation on Specialty Packaging Solutions• Refrigerated Trucking Services• GMP Compliant Depot Storage Facilities in Argentina, Australia, Brazil, Chile, China, Colombia, India, Mexico, Peru, Russia and South Africa.• Expedited Customs Brokerage• More than 149 Company Owned Offices Spanning the Globewww.worldcourier.com Sponsored by ELPRO provide high quality and innovative solutions for Cold Chain Temperature Monitoring which are easy to use and help reduce cost in the Cold Chain. Our products include the market leading Libero PDF datalogger and our services include installation, calibration and qualification. With over 20 years experience ELPRO is dedicated to supporting the Pharmaceutical and Biopharmaceutical industries. www.elpro.com The Intelleflex® Pharmaceutical Cold Chain Solution provides you with on-demand visibility for tracking and monitoring the temperature of biologics and other pharmaceuticals throughout the cold chain. With Intelleflex XC3 Technology™, you can easily and cost-effectively monitor the temperature and condition of the product every step of the way while its in-transit – without unpacking – to ensure efficacy and product quality. For more information, visit www.intelleflex.com Movianto UK is a subsidiary of the Europe-wide Movianto Group, a leading logistics and distribution service provider for the pharmaceutical and healthcare industry. With a pallet storage capacity of over 50,000 spaces as well as seven strategically located warehouses and depots throughout the country, Movianto UK is able to deliver to every UK hospital and pharmaceutical wholesaler on a daily basis with its own fleet. The company also delivers cold chain and ambient medicines and healthcare products to supermarkets, pharmacies, GPs, nursing homes and direct to patients’ homes on a next day basis. The Movianto Group operates in 13 European countries offering a total storage capacity of 225,000 pallet spaces. Movianto is a business unit of Celesio AG. More information on www.movianto.com For over 30 years, QuickSTAT has played a critical role in managing clinical trial logistics for all phases of research and drug development. We specialise in global shipping of time and temperature-sensitive clinical research samples, investigational drugs, clinical trial supplies, vaccines and dangerous goods. www.qicstat.com Yourway Transport has set the standard for quickness, dependability and personalized service within the global pharmaceutical logistics industry. Our expertise includes ambient and cold chain premium courier services, consultation on global transport requirements, customs clearance, sourcing and provision of shipping supplies and logistical project management. Yourway also provides an established network of strategically positioned, cGMP Depots, in regions such as Latin America, Europe, Eastern Europe, India, South Africa, Australia and Asia. The depot network is supported via a proprietary management system that provides immediate visibility to all transactions related to their product and studies. Please visit our website at www.yourwaytransport.comSPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy.Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussionspecific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences pleasecall: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.ukWant to know how you can get involved?Interested in promoting your pharmaceutical services to this market?Contact Margaret Mugema, SMi Marketing on +44 (0)20 7827 6072, or email: mmugema@smi-online.co.uk
  6. 6. COLD CHAIN DISTRIBUTION Conference: Monday 5th & Tuesday 6th December 2011, Marriott Regents Park, London, UK 4 WAYS TO REGISTER www.coldchain-distribution.comFAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, Great GuildfordPHONE on +44 (0) 870 9090 711 Business Square, 30 Great Guildford Street London, SE1 0HS, UK EARLY BIRD □ Book by 30th September to receive a £100 off the conference price DISCOUNT CONFERENCE PRICES I would like to attend: (Please tick as appropriate) Fee Total □ Conference & Half-Day Workshop £1998.00 +VAT £2397.60 □ Conference and Two Half-Day Workshops £2597.00 + VAT £3116.40 □ Conference only £1399.00 + VAT £1678.80 □ Half-Day Workshop only £599.00 + VAT £718.80Unique Reference Number □ Two Half-Day Workshops only £1198.00 + VAT £1437.60Our Reference LVP-012 Workshop A □ Workshop B □ PROMOTIONAL LITERATURE DISTRIBUTIONDELEGATE DETAILS □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80Please complete fully and clearly in capital letters. Please photocopy for additional delegates.Title: Forename: GROUP DISCOUNTS AVAILABLE The conference fee includes refreshments, lunch, conference papers and accessSurname: to the Document Portal containing all of the presentations.Job Title:Department/Division: VENUE Marriott Hotel Regents Park, 128 King Henrys Road, London, NW3 3STCompany/Organisation:Email: □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711,Address: email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712Town/City: DOCUMENTATIONPost/Zip Code: Country: I cannot attend but would like to purchase access to the following DocumentDirect Tel: Direct Fax: Portal/paper copy documentation Price TotalMobile: □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80Switchboard: □ The Conference Presentations – paper copy £499.00 - £499.00Signature: Date: (or only £300 if ordered with the Document Portal)I agree to be bound by SMis Terms and Conditions of Booking.ACCOUNTS DEPT PAYMENTTitle: Forename: Payment must be made to SMi Group Ltd, and received before the event, by one of theSurname: following methods quoting reference P-012 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. PleaseEmail: 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 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18Town/City: □ Cheque We can only accept Sterling cheques drawn on a UK bank.Post/Zip Code: Country: □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges.Direct Tel: Direct Fax: Card No: □□□□ □□□□ □□□□ □□□□Terms and Conditions of Booking Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX cardPayment: If payment is not made at the time of booking, then an invoice will be issued and must bepaid immediately and prior to the start of the event. If payment has not been received then credit 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. Cardholder’s Name:Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, anotherdelegate 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 a I agree to be bound by SMis Terms and Conditions of Booking.substitute, then we will refund/credit 50% of the due fee less a £50 administration charge,providing that cancellation is made in writing and received at least 28 days prior to the start of the Card Billing Address (If different from above):event. Regretfully cancellation after this time cannot be accepted. We will however provide theconferences documentation via the Document Portal to any delegate who has paid but is unable toattend for any reason. Due to the interactive nature of the Briefings we are not normally able toprovide documentation in these circumstances. We cannot accept cancellations of orders placedfor Documentation or the Document Portal as these are reproduced specifically to order. If we haveto cancel the event for any reason, then we will make a full refund immediately, but disclaim anyfurther liability.Alterations: It may become necessary for us to make alterations to the content, speakers, timing,venue or date of the event compared to the advertised programme.Data Protection: The SMi Group gathers personal data in accordance with the UK Data ProtectionAct 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other VATproducts and services. 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

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