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Cold Chain Storage & Distribution Europe


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VIBevents’ 7th Annual Cold Chain Storage and Distribution conference will bring together key manufacturers and industry experts to discuss these amongst other core issues. From understanding key transport, packaging, validation and qualification methods to optimising strategies for storing biotech and pharma products, this event will provide a platform to debate best practice approaches.

Once again, this event will be co-located with our established Clinical Trial Supply event in order to provide you with more opportunities to interact and exchange ideas with peers from both backgrounds.

Published in: Health & Medicine, Business
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Cold Chain Storage & Distribution Europe

  1. 1. Organised by: VIBpharma 7th Annual Cold Chain Storage and Distribution Tuesday 23 and Wednesday 24 February 2010, London, UK • Co-lo with cated Achieve control throughout your cold chain o Annu ur 11th al Cli processes and ensure full compliance with Trial nic Supp al confe ly current and upcoming regulations rence DISTINGuISHED SPEAKERS INCLuDE: BRAND NEW CASE STuDIES THIS Viliam Kovac, Vice President Quality and Divisional Export YEAR WILL uNCoVER: Control, RoCHE DIAGNoSTICS • How to overcome the challenge of keeping the Fabio Mioli, Senior Manager, Commercial Office and temperature stable for 2-8°C and frozen shipments Distribution, WYETH PHARMACEuTICALS/PFIZER • Techniques for making the right cold chain decisions Bert janssen, Manager QA Supply Chain, Quality Assurance Pharmaceutical, Operations Beerse, Janssen early to optimise your supply chain processes Pharmaceutica, joHNSoN & joHNSoN • Why conducting a risk assessment is a crucial part Maria Dorazio, EMEA Distribution Manager, of your validation in guaranteeing a safe cold chain BRISToL-MYERS SQuIBB process from start to finish Angelique Keijzer, Clinical Support Manager, SANoFI-AVENTIS • Current regulatory trends in ambient temperature Eric Delestre, Marketing Affiliates Quality Assurance control and how to implement auditing systems Associate, ELI LILLY cost-effectively Maurizio Caschera, GDP Responsible & Regulatory Affairs Executive, SANoFI PASTEuR MSD Ilona Zwernemann, Manager ADM and GMP Logistics, ENGAGE WITH INDuSTRY LEADERS INCLuDING: BAYER HEALTHCARE • MHRA • BRISToL-MYERS SQuIBB Michael Krahe, Manager Cold Chain Operations/Logistics, • joHNSoN & joHNSoN • RoCHE DIAGNoSTICS BAYER HEALTHCARE • ELI LILLY • WYETH/PFIZER Saddam Huq, Cold Chain Technology Lead, WYETH PHARMACEuTICALS/PFIZER • SANoFI-AVENTIS • BFARM Cornelia Nopitsch-Mai, Scientist, Federal Institute for Drugs and Medical Devices Germany, BfArM Ian Holloway, Manager, Defective Medicines Reporting A choice of interactive roundtable discussions Centre, MHRA on all the most challenging issues! REGISTER NoW: ■ online: ■ Email: ■ Tel: +44 (0)20 7753 4268 ■ Fax: +44 (0) 20 7915 9773 Gold Sponsor: Silver Sponsors:
  2. 2. Programme Day One Tuesday 23 February 2010 08:30 Registration and coffee chain management is transferred from the manufacturer to the customer and assessing the potential risk for a 08:55 opening remarks from the Chair manufacturer if the cold chain is not respected by the customer Qualifying cold chain shipments while ● Outlining the main actions a manufacturer can implement validating components and performance in order to mitigate the risk on his product through continuous monitoring Maurizio Caschera, GDP Responsible & 09:00 Conducting qualification studies of ambient Regulatory Affairs Executive, SANoFI PASTEuR MSD temperature shipping packages and systems in order to comply with global standards and giving a 10:30 Morning refreshments regulatory update ● Clarifying the key regulatory requirements on ambient 11:15 overcoming cold chain challenges when distributing temperature control to emerging countries highlighting operational and ● Advising pharma and biotech companies for developing an regulatory solutions to be implemented effective global ambient temperature strategy ● Qualifying potential routes in countries with less • Setting up a thermal mapping on ambient and trailer established infrastructure: outlining potential alternatives conditions to identify which temperature extremes the that ensure safe cold chain distribution shipping is exposed to ● Assessing related risks and picturing scenarios to tackle • Utilising temperature profiles typical for the type them effectively of packaging used to assess the period of time the ● Identifying best qualified 3rd parties for various types of temperature is kept on constant shipments and understanding how to cooperate with them • Establishing if passive and/or active cooling systems are successfully needed based on the ambient temperature the shipping ● Understanding local regulations and evaluating whether will be facing further safety measures need to be implemented to ● Ensuring appropriate handling of the product through logistics minimise risk solutions providers by clarifying responsibilities in order to ● Implementing an appropriate quality system to optimise guarantee the product quality is kept on a high standard the distribution process on a non-qualified route ● Establishing appropriate quality check and auditing systems Roger Price, Director Business Development, ClinStar, for your own cold chain structure IMP LoGISTICS Ian Holloway, Manager, Defective Medicines Reporting Centre, MHRA 11:45 Moving towards a global cold chain: entering new countries whilst finding reliable local service providers 09:30 Carrying out a risk assessment as a crucial part of and complying with international regulations the validation process and driving factor of costs to ● Assessing the infrastructure of the destination country in guarantee a safe cold chain terms of routes, storage facilities and customers available ● Executing stability studies and evaluating stability data of as well as related risks products to be shipped and stored ● Debating how to find the right couriers for small and large ● Establishing risk factors in connection with all components quantities and how to manage them successfully: executing involved such as packaging, shipping trailers and storage audits and using reliable monitoring systems facilities ● Uncovering how to manage the distribution process on a ● Assessing the risk to be considered with regards to non-qualified route whilst minimising risk operations and handling of products such as number and ● Understanding local regulations and practices in order to duration of stop-overs validate packaging and cooling systems and qualify 3rd ● Rating all factors and identifying how to handle the risks parties accordingly that need to be faced effectively ● Implementing a simple quality system that ensures process ● Balancing risk and cost based on the determination of safety and control as well as integrity of the product safety margins in order to ensure a smooth cold chain Robert Arendal, Chairman, CooL CHAIN ASSoCIATIoN process within budget Viliam Kovac, Vice President Global Quality and Divisional 12:15 Clarifying current and upcoming international cold Export Control, RoCHE DIAGNoSTICS chain regulations and how to implement them Going global: how to enter new markets, effectively in order to ensure full compliance Outlining national and GDP (Good Distribution Practice) comply with regulations and overcome ● regulations and guidelines relevant to cold chain equipment operational challenges and processes 10:00 Debating the difficulty of making sure that your ● Exploring European requirements regarding stability data of product arrives in the right condition and outlining products requiring cold chain storage the possibilities to ensure the cold chain until ● Highlighting the ongoing discussion on the European field product administration regarding transport conditions ● Presenting a case study on the administration of a ● Clarifying stability issues of pharmaceutical bulk products medicinal product by the doctor: how to ensure a successful and assessing how to overcome them standardised cold chain management from your warehouse Cornelia Nopitsch-Mai, Scientist, Federal Institute for Drugs to the administration of the product to the patient and Medical Devices Germany, BFARM ● Comparing the regulatory requirements for manufacturers, distributors, wholesalers and pharmacists regarding storage 12:45 Lunch and distribution: outlining guidelines on Good Distribution Organised by: (GDP) defined by WHO and national regulatory Practice bodies such as the Irish Medicines Board ● Debating at what stage the responsibility for the cold
  3. 3. Programme Day One Programme Day Two 08:30 Registration and coffee 14:15 RouNDTABLE AFTERNooN SESSIoNS 08:55 Opening remarks from the Chair Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key Controlling cold chain processes effectively to topics. Each session will be chaired by an industry expert ensure product safety and integrity who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect 09:00 Case study: outlining the key elements of temperature of cold chain storage and distribution. A 45 minute and quality management and how these contribute afternoon refreshment break will take place after the successfully to your overall distribution strategy first roundtable session. ● Identifying what a pharmaceutical company aims for in terms of successful temperature management in accordance to Roundtable 1: Identifying and managing risk in cold current regulations chain shipping by assessing clear actions to be taken ● Highlighting which solutions are in place by temperature control solution providers and exploring future trends to in case of jeopardized process safety optimise the outcome Establishing and evaluating risk factors throughout all ● Learning how to ensure effective quality management by stages of cold chain and balancing risks while keeping • Developing internal cold chain guidelines and updating processes aligned with determined safety margins quality agreements Sue Lee, Manager, BioPharm Systems, Research and • Establishing detailed cold chain documentation according Development, WoRLD CouRIER to regulatory requirements • Auditing cold chain capabilities and qualifying shipping Roundtable 2: Assessing current regulatory trends lanes and road and air transportation equipment with respect to monitoring ambient temperature ● Uncovering how to implement these successfully in your shipments and how to implement a monitoring system overall distribution process map and distribution strategy cost-effectively Maria Dorazio, EMEA Distribution Manager, Clarifying upcoming guidelines to establish a strategy BRISToL-MYERS SQuIBB on how to monitor ambient temperature shipments 09:30 overcoming challenges related to the control of frozen effectively, in compliance with new standards and with shipments and uncovering solutions to validate minimal cost involved reliable freezers and qualify shippers Wim van Bon, President, European Cold Storage and ● Presenting regulatory developments and trends with respect to Logistics Association, ECSLA frozen shipments in Europe ● Finding the right technology or solution provider who is able to Roundtable 3: Debating the difficulty of making sure develop a freezer system that matches your needs that your product arrives in the right condition when ● Establishing ways to validate your packaging and freezing administered to the patient devices successfully in order to ensure integrity of your Discussing at what stage the responsibility for cold chain products at all times management is transferred from the manufacturer to the ● Qualifying shippers that are able to guarantee safe handling customer and assessing the potential risk for a manufacturer and delivery if the cold chain is not respected by the customer ● Analysing defrost cycles of the products in order to establish Maurizio Caschera, GDP Responsible & Regulatory Affairs when the product quality is jeopardized in case of failure of the Executive, SANoFI PASTEuR MSD cooling system ● Identifying approaches to remedy the breakdown of a freezing system to ensure the temperature is kept within the Roundtable 4: Identifying alternative means and required limit ways of cold chain distribution while keeping the Marc Weinzweig, QP (Qualified Person) and Founder, BIoTEC required quality standards Evaluating alternative solutions including new distribution 10:00 Case study: Dealing with temperature excursion channels while keeping your distribution processes flexible successfully in a challenging environment and efficient ● Addressing the Italian logistics system to explore and Ilona Zwernemann, Manager ADM and GMP Logistics, understand characteristics and challenges BAYER HEALTHCARE ● Outlining temperature excursion risks and potential issues for biotech drugs and vaccines Michael Krahe, Manager Cold Chain operations/Logistics, ● Explaining selected systems and solutions to ensure the BAYER HEALTHCARE maximum safety level ● Debating the trends of cold chain logistics and exploring new solutions of some of the main players 18:00 Closing remarks from the Chair and end of day one Fabio Mioli, Senior Manager Commercial office and Distribution, WYETH PHARMACEuTICALS/PFIZER 10:30 Morning refreshments 11:15 Implementing cold chain controls from manufacturing to distribution for cold chain pharma products ● Understanding national and international regulations on temperature requirements in terms of ambient, 2-8°C or dry ice shipments ● Evaluating acceptable excursions based on stability data ● Assessing distribution and production scenarios from the manufacturing site to the last mile
  4. 4. Programme Day Two Wednesday 24 February 2010 ● Identifying the risks and challenges on each distribution level 14:45 Reviewing airfreight shipment of cold chain products and establishing strategies to overcome them cost-effectively using PAG shippers ● Implementing lean documentation practices to support the ● Identifying the system design and temperature quality of the product specification of the product ● Checking that all shippers are well informed about product ● Assessing shipping lanes and routes to be considered handling requirements and implementing a monitoring system and how to qualify them to ensure product safety ● Exploring the challenges to keep the temperature stable Bert janssen, Manager QA Supply Chain, Quality Assurance within the specification of 2-8°C and how to overcome them Pharmaceutical, operations Beerse, janssen Pharmaceutica, ● Outlining the options of green credentials for cold chain joHNSoN & joHNSoN products and how to secure them Saddam Huq, Cold Chain Technology Lead, uncovering techniques for making the right cold WYETH PHARMACEuTICALS/PFIZER chain decisions early to optimise the process 11:45 Managing cold chain and ambient storage facilities to 15:15 Closing remarks from the Chair and close of the actively preserve valuable supplies conference ● Electronic vs. mechanical temperature monitors: which perform best? ● Assessing how to implement adequate temperature monitoring in a study site ● Outlining best practice temperature control methods: ambient and temperature specific product distribution ● Managing deviation and guaranteeing your product stability through comprehensive temperature control and monitoring strategies Angelique Keijzer, Clinical Support Manager, SANoFI-AVENTIS 12:15 Lunch 13:45 outlining the cold chain distribution of medical samples: what are options, challenges and how to overcome them ● Presenting the different existing options for the distribution of medical samples ● Clarifying the regulatory requirements and how to ensure compliance ● Describing options of storage and assessing the pros and cons ● Exploring current ways of transportation and addressing issues faced ● Explaining the equipment used ● Clarifying which parts of the process can be qualified and how to achieve full qualification ● Identifying how to optimise the process by quality issues management Eric Delestre, Marketing Affiliates Quality Assurance Associate, ELI LILLY 14:15 Presenting strategies to plan cold chain storage effectively and establishing approaches to make storage activities cost-efficient ● Evaluating storage in centralised vs. decentralised supply chain systems in order to find the best solution for your cold chain distribution ● Planning the storage process: using a reduced number of distribution centres as a result of consolidation activities ● Keeping your storage planning flexible to avoid shortage of space ● Assessing the number, service range and quality of local contractors to establish whether all product handling requirements can be met cost-effectively ● Developing approaches to make the entire storage process more cost-efficient ● Managing internal and external warehouses and staff effectively: actions to be taken and checklists to be used Wim van Bon, President, European Cold Storage and Logistics Association, ECSLA
  5. 5. Gold Sponsor: Multi Pharma offer worldwide comparator drug sourcing for clinical trials. With facilities in Switzerland, Germany World Courier handles approximately 80% of the and New Jersey we fulfill needs of single lot, long expiration clinical trials market worldwide requiring a premium date, Certificate of Analysis, Material Safety Data Sheet, courier service. Specialists in packaging and airfreight GMP Certificate, samples, etc. We have the capacity and experience to qualification, compliance and dangerous goods, operating Best Practice in supply large amounts fast directly from the manufacturer. temperature sensitive pharmaceuticals 24x7x365 service; all shipments leave on next-flight-out; all packing materials to UN specifications; real-time web tracking and email alerts; ISO 9001 certification worldwide Phase Forward is a leading provider of integrated data management solutions for PAREXEL International is a leading global bio/ clinical trials and drug safety. The company offers proven solutions pharmaceutical services organization offering for electronic data capture (InFormTM), phase I clinic automation significant expertise from drug development and regulatory consulting to (LabPasTM), clinical data management (ClintrialTM), clinical trials clinical pharmacology, clinical trials management, medical education and signal detection (CTSDTM), strategic pharmacovigilance (Empirica reimbursement. This expertise is enhanced by industry-leading technology SignalTM) and Signal Management, adverse event reporting (Empirica solutions from its Perceptive Informatics division through medical imaging, TraceTM), applied data standards (WebSDMTM) and Web-integrated CTMS, IVRS/IWRS and integration services. interactive response technology (Clarix™). In addition, the company provides services in the areas of application implementation, hosting Silver Sponsors: and validation, data integration, business process optimization, safety data management and industry standards. Additional information about Almac offers an integrated supply chain management Phase Forward is available at solution that draws on the expertise of its best in class clinical trial supplies and IVR/web based services. Its IMP Logistics’ core business is investigational integrated solution does more than just combine related services under one medical products and clinical materials roof; it incorporates supply planning, technology implementation, and project warehousing, distribution, import licensing and customs clearance. IMP oversight into a unified study start-up and management approach that optimises Logistics is focused on clinical trials and because of this specialization the supply chain at each level. Almac and its affiliated companies provide a broad its reputation and business has grown rapidly in recent years. IMP range of services across drug discovery, diagnostics, pharmaceutical research Logistics is now established as the leading facility of its type in Russia and development, API manufacturing, clinical trials and drug manufacturing. US and Ukraine. operations are based in Pennsylvania, North Carolina and California. European operations are headquartered in Craigavon, Northern Ireland with additional operations in London and Edinburgh. Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefits. These products simplify Penn Pharma is a leading provider of integrated product dispensing and administering of pharmaceuticals, enhance drug safety development and custom manufacturing services to the and clearly reduce process costs. As a long-standing expert partner of international healthcare industry including formulation the pharmaceutical industry, Schreiner MediPharm offers a range of and analytical development, clinical trial supply, custom manufacture, customized products and services specifically addressing the complexity high containment processing, CMC consultancy and QP release services. of clinical trials. Penn manufactures to GMP and is MHRA licensed and FDA inspected. Durbin text - Durbin is a specialist provider of comparator drugs for clinical trials. In addition Piramal Healthcare is at the forefront of custom to comparator drugs, Durbin also provides manufacturing for the Pharmaceutical Industry. Our ancillary supplies and placebos. Durbin brings global sourcing capabilities extend across the high quality development expertise,transparent pricing and global custom distribution to the and manufacture of API, Formulations and Clinical Trial Materials. Our global supply of comparators and ancillaries for clinical trials. network of services integrated across the drug life cycle, offers a unique blend of flexibility and efficiency as your CMO partner of choice. Clintrak Clinical Labeling Services, LLC. Is the industry leader in providing innovative clinical labeling MWV Healthcare Packaging is working solutions. Clintrak manufactures single panel labels, with you to turn your objectives for quality, multi-panel labels, multi-language booklet labels, performance and visual impact into one-of-a-kind packaging that really stands case report forms and blinding/code break cards. Our in-house printing out for patients. Their packaging promotes adherence and health literacy, while capability, exclusive translation/regulatory approval system and making products childproof and tamper resistant, senior-friendly, traceable and expertise in clinical label design will streamline the label segment of compliant for the clinical trial, OTC and ethical drug markets. yourtrials. Last year alone, Clintrak produced over 20 million labels for clinical trials use! Clintrak is a member of Fisher BioPharma Services Biotec is a UK based Clinical Trials Supply company Division and Thermo Fisher Scientific. focusing on the import, Qualified Person certification, labelling, assembly, storage and world-wide distribution of clinical trial supplies for Phase I to IV trials, through to commercial supplies. We specialise in handling temperature sensitive biopharmaceuticals from controlled ambient conditions to 2-8°C, -20°C and -80°C. Yourway Transport has set the standard for quickness, dependability and personalized service within the transportation industry. Today speed of delivery is no longer the only consideration. Temperature control, specialized packaging, multicentre coordination, just- in-time logistical supply chain solutions, enhanced computer and information requirements are also of vital importance. Our ongoing commitment is to earn the trust and confidence of our customers by providing consistent, reliable service and communication. Combine our years of operational experience with some of the best information systems in the industry and it’s easy to see why Yourway Transport continues to be the market leader. Tourtellotte Solutions produces leading applications for the pharmaceutical industry – tcVisualize for clinical supply simulation - Fusion for document processes - Trident for next generation IWR, - and builds custom enterprise solutions for Fortune 500 companies worldwide.
  6. 6. Exhibitors: GE Sensing & Inspection Technologies Media Partners: World Pharmaceutical Frontiers
  7. 7. Booking Form 7th Annual Cold Chain Storage and Distribution Tuesday 23 and Wednesday 24 February 2010, London, UK Prices & Payment Information (please tick option) Four Easy Ways To Book: Yes, I would like to register for the event: BEFoRE BEFoRE BEFoRE AFTER ■ Register online at 25.11.2009 23.12.2009 20.01.2010 20.01.2010 Pharma manufacturers and Biotechs ■ Email us at I would like the VIP attendees package to include €2450 €2590 €2730 €2940 ■ Tel +44 (0)20 7753 4268 the two day conference + interactive CD-ROM (VAT where (VAT where (VAT where (VAT where (saving €70) applicable) applicable) applicable) applicable) ■ Fax +44 (0)20 7915 9773 I would like to attend the two day conference only €1820+VAT@ €1960+VAT@ €2100+VAT@ €2310+VAT@ Venue Details 17.5% = €2138.50 17.5% =€2303.00 17.5% =€2467.50 17.5% =€2714.25 The two day conference will take place on Academic/Government representatives Tuesday 23 and Wednesday 24 February 2010. I would like the VIP attendees package to €1540 €1680 €1820 €2030 The venue will be a centrally located hotel in include the two day conference + interactive (VAT where (VAT where (VAT where (VAT where London, UK. For further information contact our CD-ROM (saving €70) applicable) applicable) applicable) applicable) Operations department on +44 (o) 207 753 4201. I would like to attend the two day conference only €910+VAT@ €1050+VAT@ €1190+VAT@ €1400+VAT@ Are you registered? 17.5% =€1069.25 17.5% =€1233.75 17.5% =€1398.25 17.5% =€1645.00 You will always receive an acknowledgement of Fee for other participants (Non Pharma Manufacturers/Biotechs) your booking. If you do not receive anything, I would like the VIP attendees package to include €3450 €3590 €3730 €3940 please call us on +44 (0) 20 7753 4268 to make the two day conference + interactive CD-ROM (VAT where (VAT where (VAT where (VAT where sure we have received your booking. (saving €70) applicable) applicable) applicable) applicable) ALL ToTAL FEES ARE SuBjECT To A 2.5% SERVICE CHARGE I would like to attend the two day conference only €2820+VAT@ €2960+VAT@ €3100+VAT@ €3310+VAT@ 17.5% =€3313.50 17.5% =€3478.00 17.5% =€3642.50 17.5% =€3889.25 All participants I cannot attend the conference but would like to €700 (VAT where €700 (VAT where €700 (VAT where €900 (VAT receive the interactive CD ROM applicable) applicable) applicable) where applicable) Total Discount code if applicable _________________________________ Discounts are at the discretion of VIBevents and are not cumulative Vibpharma Conference Delegate terms and conditions • If you are a Biotech/Pharma Manufacturer and have signed up as a free of charge delegate, you will incur 1. Scope of Agreement: These are the conditions of the contract between you, the Client (“You” and “your”) and a charge of $499 if you cancel your registration. 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The terms of any other • This agreement is governed by and will be construed in accordance with English law and each party electronic communications will not form part of this agreement. irrevocably agrees that the courts of England will have the non-exclusive jurisdiction to deal with any disputes 2. Our commitment to you: Should the Event be cancelled or the location be changed for reasons or arising out of or in connection with this agreement. circumstances beyond our control, we reserve the right to reschedule the Event, including changing the location, • Vibpharma is subject to the UK Data Protection Act 1998 and is registered in the UK with the Information upon written notice to you. Should the event fail to be rescheduled for any reason your refund shall not exceed Commissioner to process your personal information. 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