Outsourcing In Clinical Trials West Coast


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Outsourcing in Clinical Trials West Coast will bring together pharma and biotech manufacturers to share solutions to strategic and operational challenges in outsourcing. Attendees will generate new ideas to save time and cost and increase the return on your outsourcing investment. Located in San Francisco, this event will cover topics including developing an effective selection strategy, measuring agreed outcomes, choosing between tactical and strategic outsourcing, managing multiple vendors, measuring ROI and effectively managing trials run in emerging markets – key components to help you get the most out of your outsourcing investment.

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Outsourcing In Clinical Trials West Coast

  1. 1. VIBpharma OUTSOURCING IN WEST CLINICAL TRIALS COAST Wednesday 27 and Thursday 28 January 2010, San Francisco, USA Supplier selection strategies and vendor management processes to maximize the return on your outsourcing investment HEAR FROM KEY INDUSTRY SPEAKERS: KEY REASONS TO ATTEND: Gavin Choy, Vice President, Timothy McNamara,  Improve your long-term outsourcing strategies Clinical Operations, SUPERGEN Vice President, to overcome clinical trial challenges in the Clinical Research current economic climate Nancy Havrilla, Senior Director, and Medical Affairs, Clinical Operations, ACHAOGEN  Take away ideas on CRO selection and ISTA PHARMACEUTICAlS techniques to maximize the return on your lorna Dean, Director, outsourcing investment from proven methods Rafael Escandon, SPM-Supplier Performance that demonstrate value for money Vice President, Clinical Management, AMGEN Develop more robust project management Operations, CYTOKINETICS  Raymond Starling, Senior processes through case studies highlighting Director, Clinical Development Jacqueline Mardell, strategies to ensure smooth, cost effective and Senior Director, Clinical successful trials and Operations, ATHERSYS Operations, METABOlEx  Discover ways you can improve your offshoring Christina DiArcangelo, strategy and make the most of opportunities for Associate Director, Francie Kivel, conducting trials in emerging countries Clinical Contracts and Senior Director, Clinical Trials, Outsourcing, FIBROGEN AASTROM BIOSCIENCES Susan Iovino, Director, Elizabeth Shewell, TOP COMPANIES REPRESENTED: Clinical Operations, Director, Outsourcing, INCYTE CORPORATION ● BAYER ● ISTA NOVABAY PHARMACEUTICAlS PHARMACEUTICALS PHARMACEUTICALS Todd Reul, Associate Director, Maria Madison, Director, AMGEN ● ● ATHERSYS Clinical Outsourcing, Clinical Operations, ● FIBROGEN ENANTA PHARMACEUTICAlS ● AASTROM FACET BIOTECH ● FACET BIOTECH BIOSCIENCES Henry Brandon, ● NOVABAY PHARMACEUTICALS ● ACHAOGEN Regional Head North America, Global Strategic Outsourcing, ● METABOLEX ● INCYTE BAYER PHARMACEUTICAlS ● CYTOKINETICS CORPORATION Gold sponsor: Silver sponsors: , INC. REGISTER NOW: Online: www.vibpharma.com/outsourcing/west Tel: +44 (0)20 7753 4268 Email: book@arena-international.com Fax: +44 (0)20 7915 9773
  2. 2. Program Day One Wednesday 27 January 2010 8:30 Registration 11:40 Risk management for small pharma and biotechs: making the right decision on how much to outsource 9:00 Opening remarks from the Chair ● Avoiding costly and critical mistakes that can cripple small biotechs Maria Madison, Director, Clinical Operations, ● Compare full service versus functional outsourcing models and the ENANTA PHARMACEUTICAlS implications for small scale trials ● Finding CROs with the right level of expertise and experience in Sustainable strategies to safeguard the return on similar sized trials your outsourcing investment ● Ensuring that your trial is given the resources and time it needs when competing with large scale trials 9:10 Keynote presentation: Christina DiArcangelo, Associate Director, Clinical Contracts and Outsourcing in uncertain times: asset management Outsourcing, FIBROGEN strategies for long term survival Getting the balance right between retaining in-house capacity and ● 12:10 The CRO selection process: how it can hinder or help relying on CROs ● Making the most of the opportunities for cost savings and cheaper identifying the best possible partner trials in the current economic climate ● Operating a preferred provider list versus a competitive tender ● Strategies for leveraging CROs on cost in a competitive market process: over-reliance versus a lengthy inefficient selection process? ● Identifying solutions to project management resource obstacles to ● Avoiding path dependency on the selection processes without ensure a smooth trial process reinventing the wheel Gavin Choy, Vice President, Clinical Operations, SUPERGEN ● Assessing strengths and weaknesses of potential partners using case study data and like for like comparison tools ● Saving time through developing your own bid grid for CROs to 9:40 Making the right outsourcing decision first time: submit proposals avoiding a chop and change approach to reduce ● Ensuring consistent understanding and interpretation amongst costly errors vendors of sponsor expectations, timelines and budgets ● Understanding and setting manageable expectations of your Maria Madison, Director, Clinical Operations, ENANTA trial partner PHARMACEUTICAlS ● Taking the time to get the contract right to save time during trials ● Making decisions on the basis of evidence and sustained 12:40 Lunch trial output ● Managing the pressure to get results quickly without compromising your trial 2:00 Implementing optimal outsourcing strategies to ● Knowing when to end a relationship and preventing rushed safeguard the future of the virtual pharma model decisions on the effectiveness of a CRO ● Outlining the present trends for virtual pharma companies and Nancy Havrilla, Senior Director, Clinical Operations, ACHAOGEN implications for the outsourcing model ● Solutions for cutting costs without compromising drug development activities in the current funding crisis 10:10 Managing costs and expenditure in outsourced ● Identifying expertise and guidance on cost effective alternatives to clinical trials outsourced functions ● Understanding how trial costs are calculated to enable better ● Finding the right trial partner to fit your business model and size, is decision making bigger always better? ● Addressing the cost implications of outsourcing different functions ● Managing delays due to unexpected factors controlled by suppliers ● Getting value for money from CRO partners to ensure timelines are kept on track ● Evaluating inconsistencies between CRO pricing models and how to ● Avoiding common time and cost overruns and ensuring the best interpret them service from your CRO ● Measuring ROI on outsourced trials A panel of speakers from the two days will discuss and take ● Quantifying the value of a partnership for quicker decision making questions on this important issue on future trials lorna Dean, Director, SPM-Supplier Performance Management, AMGEN 2:30 Offshoring to emerging countries: reducing costs and achieving consistency in uncertain trial environments ● Understanding the nuances of the changing regulatory 10:40 Morning Refreshments environments in offshore clinical trials to better manage trial risks ● Know your environment: an up-to-date picture of standards in the EU, India and China Improving selection processes to minimize risk and ● Matching trials to the right country: evaluating trial requirements maximize time and cost savings with different regulatory and environmental factors ● Choosing CROs that have credible and substantiated experience in 11:10 Ensuring trial partners are fit for purpose by trials with key groups implementing an efficient and thorough Jacqueline Mardell, Senior Director, Clinical Operations, METABOlEx selection process ● Determining your selection criteria for seeking out the right quality partner 3:00 Panel Discussion: ● Gathering information on potential partners to ascertain capabilities Metrics and KPIs for improving trial processes and strengths ● Standardization of trial functions and use of metrics to measure ● Measuring track records and expertise: using case studies to gauge desired outcomes competencies ● Identifying CROs that can operate within the framework of your KPIs ● Mitigating inherent risks in outsourcing: ensuring your contract ● Ensuring compliance with in-house processes and protocols covers all areas of the timeline, service and budget during the ● Improving the sponsor’s ability to control and monitor studies negotiation stage in order to significantly reduce trial times ● Establishing a relationship prior to selection to get the trial off to the A panel of speakers from the two days will discuss and take best start questions on this important issue Raymond Starling, Senior Director, Clinical Development and Operations, ATHERSYS
  3. 3. Day One Wednesday 27 January 2010 Program Day Two 3:30 Afternoon refreshments 8:30 Registration 9:00 Opening remarks from the Chair A step-by-step approach to selecting trial partners to Rafael Escandon, Vice President, Clinical Operations, avoid costly errors CYTOKINETICS 4:00 Identifying and selecting your short-list and preferred CRO partners Offshore clinical trials: keeping complex projects ● Looking at your organization and the specific areas that you are trying to enhance when selecting providers on time and within budget Breaking down functional areas during selection: therapeutic ● 9:10 Keynote presentation: expertise, geographic reach, clinical service areas, lab, imaging from one provider or multiple providers Ethical responsibilities of developed world sponsors ● Managing the process of canvassing the marketplace of all the conducting clinical trials in developing countries providers that offer required services and submitting Request for ● Key decision drivers supporting the conduct of your trial abroad Information (RFI) ● Appreciating cultural differences and minimizing risks of errors ● Evaluation of RFI responses and face-to-face meetings with a ● Assessment of partner’s ability to meet trial expectations subset of suppliers ● Analyzing history of ethical and GCP compliance and regulatory ● Identifying the right number of partners - how many is reasonable track record and the advantages and disadvantages of more or less ● Appropriate site selection and other resource allocation, planning ● MSA process and terms and conditions to consider while going and logistics through this process ● Patient recruitment considerations in new trial localities Henry Brandon, Regional Head, North America Global Strategic ● Site and vendor contract strategies Outsourcing, BAYER PHARMACEUTICAlS ● Sustaining local access to treatments Rafael Escandon, Vice President, Clinical Operations, CYTOKINETICS 4:30 An outcome-based approach to outsourcing: balancing cost and quality considerations for 9:40 Keynote presentation: optimal results Conducting strategic clinical trials in China: 2010 ● Focusing clinical trial processes and outsourcing decisions on ● The current status of the Chinese regulatory environment for desired outcomes conducting clinical trials ● Conducting a study-specific analysis using key factors such as the ● Clinical facilities accredited by China SFDA to conduct trials ideal patient profile, technological and expertise needs for the trial ● Advantages and disadvantages of conducting trials in China when determining whether to outsource ● Recent outcomes regarding US FDA site inspections in China ● Identifying the best opportunities for strategic partnerships ● Strategic practices to conduct successful trials: planning, ● Knowing your partner’s capabilities to determine agreed training and partnership outcomes prior to a trial Dr xiaxiong Wei, Director, Clinical Pharmacology, MEDPACE ● Determining the right level of support and monitoring for optimal results 10:10 Panel discussion: Timothy McNamara, Vice President, Clinical Research and Developing effective supply chain planning for Medical Affairs, ISTA PHARMACEUTICAlS shipping to offshore trial sites ● Planning how much supply is needed and coordinating with 5:00 Closing remarks from the Chair and end of day one trial partners ● Blinding techniques for various phases and purposes in clinical trials ● Pharmaceutical and biotech aspects of blinding comparators ● Understanding the role and responsibilities of clinical supply chain planners and managers ● Clinical supply management team structure and effectiveness ● Collaborating and working with clinical groups: challenges and opportunities A panel of speakers will discuss these issues and take questions on project management processes. Overcoming patient recruitment challenges and building flexibility into your clinical trials 10:40 Boosting patient participation and compliance using an in-home clinical service model ● Increasing patient comfort and convenience to maximize patient recruitment, compliance and retention ● Increasing efficiency by understanding what a centrally managed in- home clinical service model is and what services can be provided to study patients at their home or other convenient locations ● Effectively implementing these services and addressing the regulatory issues to optimize patient recruitment strategies ● Practical case studies: trials that effectively utilized homecare services to speed recruitment, enhance compliance and increase patient satisfaction REGISTER ONLINE NOW! Gail Adinamis, President and CEO, ClINICAl RESOURCE NETWORK www.vibpharma.com/outsourcing/west 11:10 Morning refreshments
  4. 4. Day Two Thursday 28 January 2010 11:40 Investigational medicinal products for the EU: Successful trial management: reducing change orders rules, regulations, solutions and support and keeping to budget Framework and context of EU legislation including the CTD Directive ● 3:00 Building flexibility into processes to incorporate 2001/20/EC and annex 13 to the EU GMPs under 2003/94/EC ● Practical requirements and preferences in operational GMPs changes to the scope of your trial ● Product specification files ● Negotiating budgets and agreements to ensure visibility on all sides ● Investigational medicinal product dossiers ● Understanding internal budgetary implications of change orders ● What do Qualified Persons do? ● How to determine the limits of your budgets and agreeing these ● Conducting QP audits of non EU facilities and QP declarations with your CRO for import ● Strategies to reduce the likelihood of change orders ● Provision of comparators and ‘NIMPs’ Elizabeth Shewell, Director, Outsourcing, INCYTE CORPORATION ● Answering the ten key questions for outsourcing IMP supply to the EU Paul Thomas, Chief Scientific Officer, PENN PHARMA 3:30 Afternoon refreshments Building flexibility into your processes for smoother Successful vendor management frameworks for clinical trials clinical trials 12:10 Panel discussion: 4:00 Establishing a sustainable governance relationship The impact of internal processes and diverse ● What is governance and why is it important? project teams on CRO management ● Getting internal buy-in and commitment for governance ● How to overcome internal differences in communication and ● Navigating levels of governance (executive, operational and monitoring of CROs business management) ● Developing a preferred list of providers to speed up the trial set ● Establishing metrics and identifying CROs that can operate within up process an agreed performance framework ● Using hybrid project teams to improve the relationship ● Deciding on the content to be covered by each level of governance management process ● Keeping momentum going during a trial to ensure desired ● Learning from success and failure to improve project management outcomes of outsourced trials Henry Brandon, Regional head North America, Global Strategic ● Dealing with the challenge of maintaining control and decision Outsourcing, BAYER PHARMACEUTICAlS making speed while managing internal growth A panel of speakers from the two days will discuss and take 4:30 Relationship management and partnership working questions on this important issue. Panel will also include Susan Iovino, Director, Clinical operations, NOVABAY PHARMACEUTICAlS across multi-site trials ● Giving CROs flexibility while ensuring best use of resources and minimal delays 12:40 Lunch ● Maintaining ongoing communication to ensure key deliverables and timelines are met ● Relationship management across multiple trial sites: balancing Innovation in project management to better cost decisions with the practicalities of monitoring and communication trial monitoring ● Making the right decision: keeping project management in-house 2:00 Precontract audits of CROs to reduce outsourcing risks or outsourcing to a service provider? ● Assessing the capabilities and free capacity of CROs to achieve Jason lindow, Associate Director, Clinical Operations, OxIGENE project goals ● Identifying CRO standard operating procedures to ensure ideal fit with sponsor processes 5:00 Closing remarks from the Chair and end of conference ● Quantifying impact on resource availability of subcontracted functions to third parties ● Continuous development and training of staff to keep up to date with technologies and standards ● Matching hardware and software capabilities to trial needs to ensure quick and cost efficient data analysis Francie Kivel, Senior Director, Clinical Trials, AASTROM BIOSCIENCES 2:30 Agreeing the parameters of communication and reporting by CROs during the trial process ● Ensuring that everyone knows their responsibility at the outset of a trial ● Keeping track of progress to address issues early without jeopardising outcomes ● Developing a strategic process to achieve agreed outcomes on time and on budget ● Reducing the amount of necessary oversight to increase trial efficiency and ease the burden on sponsors ● Identifying vendors with good reporting tools and transparent communication processes Todd Reul, Associate Director, Clinical Outsourcing, FACET BIOTECH
  5. 5. Sponsors and Media Partners Gold Sponsor Exhibitors Medpace is a full-service, global contract research organization (CRO) that partners with biopharmaceutical companies to bring innovative drugs to market. Medpace, based in Cincinnati, Ohio, manages global studies and regulatory submissions, providing clinical trial support in all phases of development up to and including submissions to regulatory agencies. In addition to full-service CRO functionality, Medpace has international a division of operations that include bioanalytical and pharmacology capabilities, central laboratory, and core imaging services. Medpace physicians have extensive experience conducting clinical trials and understand the issues from the perspective of the clinical investigator, the scientific leader, and the reviewer at the regulatory agencies. Medpace brings these perspectives to each clinical trial that we conduct. www.medpace.com Media partners Silver Sponsor Pharmaceutical Technology is used daily Penn Pharma is a leading provider of as a means of creating partnerships and integrated product development and as a point of reference by professionals custom manufacturing services to within the pharmaceutical industry. This comprehensive resource the international healthcare industry supplies the latest news releases, detailed information on industry including formulation and analytical projects, white papers, event information and a thorough breakdown development, clinical trial supply, custom manufacture, high of products and services. www.pharmaceutical-technology.com containment processing, CMC consultancy and QP release services. Penn manufactures to GMP and is MHRA licensed and World Pharmaceutical Frontiers: FDA inspected. www.pennpharm.co.uk The pharmaceutical industry is changing fast. World Pharmaceutical Frontiers www.worldpharmaceuticals.net There are more regulations, technologies, Clinical Resource Network, LLC is a faster product launches and shorter product life cycles than ever before. leading provider of specialized in-home World Pharmaceuticals frontiers is, and will continue to be, at the and alternate-site nursing, pharmacy forefront of these changes, so visit us at www.worldpharmaceuticals.net and phlebotomy services for phase I-IV and stay up to date with all latest developments. studies conducted in the US, Canada, UK, Drugdevelopment-technology.com: is Europe and Israel. These services decrease development time by a procurement and reference resource accelerating patient recruitment and improving compliance and providing a one-stop-shop for professionals retention. CRN supports trials in all therapeutic categories and age and decision makers within the drug development and medicines groups. CRN centrally manages an extensive network of clinicians industry. They provide a comprehensive breakdown of drug development from over 3,000 agencies with services available 24/7. Services for contractors and suppliers, up-to-date news and press releases, white taking selected protocol visits to the patient include: papers and detailed information on current industry projects and trends. • Study drug dispensing and administration (IV, injection, oral) Their recruitment area provides career information and the latest job • Blood draws (safety labs, serial pK) vacancies in the field. www.drugdevelopment-technology.com • Patient training, education and assessments www.clinicalresource.net/ Pharmaceutical Business Review: The Business Review websites are your number M2S offers a full range of image one stop for all the latest news, comment and management services, utilizing cutting- industry information. Each Business Review edge technologies to provide high-quality website offers content that is produced by a data at the lowest total delivered cost. dedicated team of journalists and global industry experts.In addition Our “end-to-end” clinical trial services to the free content made available on the sites an intelligence store include protocol development, electronic image collection, will provide you with premium market analysis reports from the leading independent radiological review, archiving and web-based data global suppliers of market research and industry analysis.Pharmaceutical reporting as well as clinical data registries and post-surveillance Business Review is the world's leading pharma website, being used data management. www.m2s.com by over 100,000 visitors every month. For further information contact jsharp@industryreview.com We offer worldwide comparator drug sourcing and distribution for clinical , INC. trials. With GDP licensed facilities in Testimonials from our past event Switzerland, Germany and New Jersey we “This has been a very informative conference. All the speakers fulfill needs of single lot, long expiration were interesting and provided a lot of information. I enjoyed the date, Certificate of Analysis, Material roundtable discussions. It was really nice to talk to all the vendors. Safety Data Sheet, GMP Certificate, samples, etc. We have the There weren’t too many and there wasn’t too little. Really enjoyed capacity and experience to supply large amounts fast directly from the two days. The setup with the breaks and lunch with the vendors the manufacturer. www.multipharmaus.com was good for interactivity.” Director, Clinical Ops. NOVOBAY “I am impressed by the quality and experience of the speakers. Do you wish to exhibit your products Learning the approaches of other sponsor speakers provides and services at this exclusive event? valuable information that I can use when dealing with vendors. Contact details: Nick McCudden, The conference has been excellent and I hope to attend again Sponsorship Manager +44(0) 207 753 4259 next year.” nicholasmccudden@arena-international.com Outsourcing and Contracts Manager, SCHWARTZ BIOSCIENCE/UCB
  6. 6. BOOKING FORM Oursourcing in Clinical Trials West Coast, Wednesday 27 and Thursday 28 January 2010, San Francisco, USA Prices & Payment Information (please tick option) Four Easy Ways To Book: ■ Register online at YES, I WOULD LIKE TO REGISTER FOR THE EVENT: PRICES www.vibpharma.com/outsourcing/west BIOTECH/PHARMA ■ Email us at I am a Biotech/Pharma VP/Director, please register my FREE place at the 2-day conference* FREE book@arena-international.com I am a biotech/pharma attendee, please register my place for the two day conference $499 ■ Tel +44 (0)20 7753 4268 I am unable to attend the conference, but I would like to receive the interactive CD-ROM $650 ■ Fax +44 (0)20 7915 9773 FEES FOR OTHER PARTICIPANTS (NON-BIOTECH/PHARMA) The two-day conference $2295 I am unable to attend the conference, but I would like to receive the interactive CD-ROM $650 Venue Details All bookings are subject to a 2.5% service charge. The two day conference will take place on Wednesday 27 and Thursday 28 January 2010. The venue for the two days will be a centrally located hotel in San FREE*: This event is strictly by invitation only. There are a limited number of FREE places to the conference Francisco, USA. For further information contact our and workshop which are reserved for VP/Directors of pharmaceutical manufacturers and biotechs only. operations department on +44 (0) 20 753 4201. Arena International Events reserves the right to allocate places, refuse applications, or to charge a nominal attendance fee for pharmaceutical manufacturers and biotechs of $499 for the conference Are you registered? once the number of complimentary places have been exceeded. All fees must be paid in advance. You will always receive an acknowledgement of your Discount code if applicable ______________________________ booking. If you do not receive anything, please call Discounts are at the discretion of Arena International and are us on +44 (0) 20 7753 4268 to make sure we have Total not cumulative received your booking. Arena International 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 a charge of $499 if you cancel your registration. 1. Scope of Agreement: These are the conditions of the contract between you, the Client (“You” and “your”) and Arena International Events Group (“Arena International Events Group”, “we”, “us” and “our”) governing your use of our 5. General: You, your executive/s or your agents may not transfer or assign any of the rights or obligations of this services, including the conference registration as set out in your booking form. This agreement constitutes the entire Agreement (in whole or part) without our prior consent. 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Registered in England No. 01155599. www.arena-international.com Delegate Details please photocopy form for multiple bookings Mr/Mrs/Ms/Dr: First Name: Surname: Email: Tel: Job Title: Fax: Department: Company Details Company: Address: Town: Postcode: Country: VAT Number: Nature of Business: Payment Details Purchase Order No. ■ I enclose a cheque drawn on a UK bank (please make cheque payable to SPG Media Ltd and write reference POUT0110 on the reverse) ■ I will transfer payment to your Lloyds TSB account City Branch, London, UK: 01492549, sort code 30-00-02 (using reference POUT0110) ■ I would like to pay with my credit card ■ Visa ■ Mastercard ■ AMEX ■ Maestro ■ Solo Card Number: Expiry Date: Issue Date: CSV*: Cardholder's Name: Cardholder's Address: *The CSV number is the last 3 digit number on the reverse of the card ■ Yes, I have read and understood the terms and cancellations conditions and am happy to proceed with my registration MK/AG Signature Date