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Optimising Clinical Development In Oncology_LI

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Making the most of the investments into developing new cancer therapies will not only increase the profits of pharma and biotech companies but will also radically alter the landscape in tackling all …

Making the most of the investments into developing new cancer therapies will not only increase the profits of pharma and biotech companies but will also radically alter the landscape in tackling all forms of cancer and give hope to sufferers that the disease is not the death sentence it once was.

However there are still a lot of challenges facing pharma and biotech comapnies. Running oncology trials pose different challenges to those experienced with traditional clinical development. The whole clinical process from patient recruitment through to data analysis and regulatory frameworks is challenging. This is where expertise and learning from experienced professionals makes all the difference.

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  • 1. 18 VE presents an ec to SA Bo pay be 50 th d ok by r a D em up £ nd 0 Enhancing patient recruitment and streamlining clinical processes to speed time to market 2-Day Conference: 27th – 28th April 2010 Pre-Conference Workshop Day: 26th April 2010 Venue: Le Meridien, Piccadilly, London, United Kingdom www.OncologySummit.co.uk Benefit from interactive case-study Engage with an expert speaker panel made up of 15 leading oncology pharma and biotech driven content that will enable you to: representatives • Improve your patient selection and retention strategies by Ridwaan Jhetam, Global Tomas Skacel, learning best practice from Wyeth, Oxigene and Eisai Clinical Operations Head: International Medical Oncology Senior Director, Amgen • Take away ideas on how to reduce cost and effectively project Director, Johnson manage the trial from GlaxoSmithKline, Roche, Schering Jai Balkissoon, Senior and Johnson Plough and Johnson and Johnson Medical Director, Mike Burgess, European Director of Oncology, • Develop more robust processes for high quality data capture Head of Oncology Oxigene and analysis to facilitate the different trial designs –Roche, Clinical Research and Shanna and Bristol Myers Squibb and present their experiences Early Development, Stopatschinskaja, Global Roche • Learn how you can make best use of biomarkers throughout Medical Director your trial from Michael Shi, Director, Biomarker Project Leader, Michael Zaiac, Assistant Oncology, Schering Exploratory Oncology Department, Novartis Vice President, Medical Plough Affairs EMEA, Michael Herschel, Join us on 26th April to gain in-depth insight into key clinical Transplant, Oncology and Director Clinical oncology challenges: GI, Wyeth Research, Workshop A: Effective risk management in clinical trial designs Michael Shi, Director, GlaxoSmithKline This workshop will cover key issues including: Biomarker Project Benedicte Akre, Medical • The "Cradle to Grave" concept of managing risk Leader, Exploratory Science Manager – • Benefit:Risk management for oncology trials and global considerations Oncology Department, Oncology, Bristol Myers • Designing an effective Target Product Profile (TPP) Novartis Squibb • Development of a Clinical Development Plan (CDP) Denis Mir, Senior • Mitigating risk with Risk Management Plans (RMP) / Risk Maps Manager, Clinical Dana Ghiorghiu,Research Led by: Helen Usmar, Director, PharmaTracks Ltd Operations – Oncology, Physician, Imaging Workshop B: The use of biomarkers in oncology trials for more Eisai Global Clinical Clinical Biomarkers effective drug development Development Group, AstraZeneca You will walk away from this workshop with new information and Angus Dalgleish, ideas on: Christiane Langer, Foundation Professor of • The validation of biomarkers Oncology, St Georges Group Medical Director, • The use of biomarkers for personalised medication Hospital Medical School Oncology Clinical • Advances in biomarker research and development Research Europe, Bristol Led by: Michael Shi, Director, Biomarker Project Leader, Exploratory Giorgio Massimini, Myers Squibb Oncology Department, Novartis Administrative Head of Oncology – Thore Nederman, Head What others have said about Pharma IQ events: Europe,Roche of Clinical Development, Great mix of presenters covering a comprehensive range Active Biotech of topics-well done. Superb networking opportunity. Pfizer Tel: +44 (0)20 7368 9300 Very valuable, learned a lot, inspired Fax: +44 (0)20 7368 9301 Novartis Pharma AG Email: enquire@iqpc.co.uk Media partners
  • 2. Workshop A: Effective risk management in clinical trial designs 10am – 1pm A This workshop will discuss strategies to reduce trial risks and errors through effective trial design to ensure that the trial risk factors are clearly identified. The aim is to match trial design to the goals of the study to minimise risks during latter trial phases and maximise the success of early phase trials. This workshop will cover key issues including: • The "Cradle to Grave" concept of managing risk • Benefit:Risk management for oncology trials and global considerations • Designing an effective Target Product Profile (TPP) • Development of a Clinical Development Plan (CDP) • Mitigating risk with Risk Management Plans (RMP) / Risk Maps Your workshop facilitator: Helen Usmar, Director, PharmaTracks Ltd Workshop B: The use of biomarkers in oncology trials for more effective drug development 2pm – 5pm This workshop focuses on biomarker applications in oncology clinical development and will explore how to apply biomarkers to B address key challenges and opportunities in developing novel cancer therapeutics. The aim is to identify how to verify the impact of novel drugs by monitoring pharmacodynamic biomarkers, evaluating molecular response and increasing drug development predictability. You will walk away from this workshop with new information and ideas on: • Validation of biomarkers • Use of biomarkers for personalised medication • Advances in biomarker research and development Your workshop facilitator: Michael Shi, Director, Biomarker Project Leader, Exploratory Oncology Department, Novartis About Pharma IQ Become a member of Pharma IQ and receive complimentary access to resources that will keep you at the forefront of industry change. You will receive access to our growing library of multi-media presentations from industry leaders, an email newsletter updating you on new content that has been added, free aggregated news feed from over 1000 global news sources tracking your industry and special member only discounts on events. Become a member here: Web: www.pharmaceuticaliq.com Phone: +44(0)20 7368 9301 Media partners Every weekly issue of Cancer Drug News reports the important news on the companies, products, alliances and research that are shaping global cancer markets with regular sections on cancers affecting the brain, breast, GI tract, genito-urinary system, gynaecological system, blood and lung as well as melanoma/sarcoma. For further information please visit: www.espicom.com/cdn Medical News Today is the largest independent medical and health news site on the web - with over 2,000,000 unique monthly users it is ranked number one for medical news on Google and Yahoo!. Medical News Today is used by Blue Chip pharmaceutical and health organizations, advertising agencies, PR companies and vertical ad networks to deliver targeted disease/condition and general health campaigns. For more information contact peter@medicalnewstoday.com or visit www.medicalnewstoday.com. www.OncologySummit.co.uk Tel: +44 (0)20 7368 9300 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk
  • 3. 08:30 Registration 14:10 Break-Out Roundtable Discussions: Participants will be able to choose 09:00 Pharma IQ Welcome and Chairperson’s Opening Address between the different roundtables and spend 45 minutes discussing the Mike Burgess, European Head of Oncology Clinical Research and points outlined below before feeding back to the group Early Development, Roche Roundtable A OPTIMAL PATIENT RECRUITMENTAND RETENTION STRATEGIES Planning and managing recruitment and retention FOR SUCCESSFUL TRIAL SETUP Optimising patient recruitment strategies to ensure the right patient profile for 09:10 Successful patient retention through communication and studies and ensure long term trial success understanding the motivation to participate in an oncology study Ridwaan Jhetam, Global Clinical Operations Head: Oncology Senior Director, • Working with patients to engage them in the study and establishing Johnson and Johnson the most effective methods to reach them Roundtable B • Listening to study volunteers and developing sustainable relationships Effective use of adaptive trial models to reduce the length of trials throughout the trial Utilising suitable trial adaptations to enable flexibility in the conduct of clinical • Knowing what patients want and need in order to maximise retention studies Michael Zaiac, Assistant Vice President, Medical Affairs EMEA, Tomas Skacel, International Medical Director, Amgen Transplant, Oncology and GI, Wyeth Roundtable C 09:50 Effective marketing and communication approaches for maximising The use of biomarkers for personalised treatment in oncology patient recruitment for a clinical study Obtaining accurate data on patient outcomes to allow investigators to make • Targeted marketing techniques to make best use of research budgets improved clinical decisions throughout the study and speed the time to market for new treatments Michael Shi, Director, Biomarker Project Leader, Exploratory Oncology • Understanding the critical importance of effective communication Department, Novartis with physicians • Providing consumable information for oncologists to communicate 14:55 Roundtable Facilitators’ Feedback to the Entire Delegation with patients 15:15 Networking Coffee Break • Innovative techniques to reach prospective patients and investigators • Determining the most effective options in directly informing patients OPTIMISING IMAGING TECHNIQUES IN ONCOLOGY about your trial DEVELOPMENT FOR IMPROVED PATIENT OBSERVATIONS Jai Balkissoon, Senior Medical Director, Director of Oncology, Oxigene 15:45 Imaging techniques to generate reliable and time sensitive data 10:30 Networking Coffee Break during a clinical study 11:00 Developing successful strategies to maximise patient enrolment • The potential of imaging techniques to advance clinical development in • Optimising your approach to recruiting patients with the right profile oncology for your study • Applications for the monitoring of treatment response during clinical • Compiling a comprehensive recruitment strategy to meet enrollment studies objectives • Utilising current technology to determine patient suitability for a trial • Key indicators to guide sponsors in determining the plan for recruitment • Attaining faster, more reliable and accurate patient data to ensure a • Engaging with study sites, CRAs and other stakeholders cost and time efficient trial • Pinpointing problems during the recruitment stage – addressing lack • How imaging innovations can impact cancer care in the future of information and working with medical professionals to increase Dana Ghiorghiu, Research Physician, Imaging Clinical Biomarkers patient enrolment Group, AstraZeneca Denis Mir, Senior Manager, Clinical Operations – Oncology, Eisai Global EFFICIENT DESIGN AND PROJECT MANAGEMENTTO KEEP Clinical Development TRIALS ON TRACK QUICKER CLINICAL DEVELOPMENTTHROUGH THE APPLICATION 16:25 The changing nature of the pharma/academia relationship and the OF ADAPTIVE TRIAL DESIGN implications for successful early clinical development 11:40 Designing an adaptive clinical trial: the costs and benefits for long • Identifying key trial goals and establishing effective communication term clinical development in oncology with clinical research partners • Developments in statistics for greater use of adaptive trial models • Establishing effective problem-solving strategies to manage trial • Considerations when designing an adaptive trial and identifying the challenges most suitable model • Agreeing action points to prevent problems with patient enrolment • Determining the most cost and time effective solution for oncology trials • Validating the success rate of early phase trials • Adopting a Bayesian approach using formal, probabilistic statements Mike Burgess, European Head of Oncology Clinical Research and Early Development, Roche of uncertainty to determine how information from various sources will be combined and how the design will change Tomas Skacel, International Medical Director, Amgen 17:05 Overcoming operational challenges in large phase III/IV oncology studies 12:20 Networking Lunch Break • Identifying key goals of the phase III/IV trial and validating the success rate of phase III trials 13:30 Panel discussion: Making the right choice in trial adaptation to maximise efficiency and speed time to market • Outlining risk factors for the phase III/IV trial to minimise the numbers of failures • Analysing outcomes to identify possible adaptations • Understanding regulatory issues and compliance with data guidelines • Identifying what can be changed through analysis of early outcomes Michael Herschel, Director Clinical Research, GlaxoSmithKline • The implications for trial logistics when changes to trial design are made • Maintaining trial blindness to ensure trial integrity 17:45 Chairperson’s Closing Remarks and Close of Day One • Assessing the pros and cons of adaptive designs
  • 4. 08:30 Registration 14:10 Break-Out Roundtable Discussions: Participants will be able to choose 09:00 Pharma IQ Welcome and Chairperson’s Opening Address between the different roundtables and spend 45 minutes discussing the Ridwaan Jhetam, Global Clinical Operations Head: Oncology Senior points outlined below before feeding back to the group Director, Johnson and Johnson Roundtable A EFFECTIVE APPROACHES TO DATA COLLECTION AND MANAGEMENT TO Execution of clinical trials in small countries – defining the right target FACILITATE REGULATORYAPPROVAL PROCESSES patient population and integration of biomarkers Overcoming challenges in recruiting patients for smaller, localised trials and 09:10 Oncology data collection, integration and analysis practical approaches to observing patient outcomes • Making the best use of available electronic tools to gather and share Benedicte Akre, Medical Science Manager – Oncology, Bristol Myers Squibb data quickly and efficiently in oncology trials • Identifying critical data elements for the most commonly used Roundtable B oncology clinical trial endpoints Phase II trial designs in oncology - what really matters? • Managing different points of data entry – effective monitoring of data Designing a phase II oncology trial to ensure an optimal outcome using common and innovative methods and preventing failure of the trial at a later stage entry and quality • Overcome the challenge of integrating data sets across multiple trial sites Christiane Langer, Group Medical Director Oncology Clinical Research Europe, Bristol Myers Squibb Benedicte Akre, Medical Science Manager – Oncology, Bristol Myers Squibb Roundtable C 9:50 Effective partnerships in oncology trials Effective partner selection and project management processes • Optimal outsourcing strategies to safeguard trial design and aims Choosing and managing CROs - building proactive relationships for effective trial • Solutions for cutting costs without compromising drug development management Thore Nederman, Head of Clinical Development, Active Biotech activities • Identifying expertise and finding the right trial partner to fit the needs 14:55 Roundtable Facilitators’ Feedback to the Entire Delegation of the trial • Project management and monitoring to minimise delays and cost 15:15 Networking Coffee Break overruns SAFETY MONITORING AND REPORTING STANDARDS FOR Angus Dalgleish, Foundation Professor of Oncology, St Georges GREATER COMPLIANCE Hospital Medical School 15:45 Panel discussion: Understanding the regulatory considerations 10:30 Networking Coffee Break surrounding cancer clinical trials 11:00 Managing the complexities of phase III paediatric oncology trials • Amendments to clinical trials guidelines for continuous safety monitoring and reporting requirements • Understanding the unique challenges and difficulties with paediatric • Detailed guidance on the collection, verification and plans for assuring clinical trials compliance with adverse event reporting • Maximising patient populations in phase III development • Monitoring the progress of trials and safety of participants and • Using biomarkers for effective patient analysis and trial adaptation assessing the toxicity and effectiveness of a treatment intervention • Managing the transition from phase I/II to phase III trials • Guidance on Investigational Medicinal Products (IMPs) used in clinical Giorgio Massimini, Administrative Head of Oncology – Europe, Roche trials SUCCESSFUL PROJECT MANAGEMENT OF CLINICAL PARTNERS • Regulatory aspects of safety reporting, general MTD, MABEL TO REDUCE TRIAL RISKS concepts, and IMP vs NIMP definitions and implications 11:40 Improving cost control in oncology trials through better supply chain MAXIMISING THE VALUE OF TARGETED THERAPIES: A CASE management and internal communication STUDY IN PERSONALISED MEDICINE • Ensuring that drugs are where you need them, when you need them 16:25 Exploring Erbitux and Kras: lessons learned for personalised medicine • Variations in import restrictions across multiple trial sites • Establishing the purpose of personalised medicine • Working with manufacturing divisions throughout the planning process • Lessons learned from Erbitux: clinical benefit without and with patient • Establishing accurate drug estimates through collaboration with selection based on Kras marketing, manufacturing and operations • Effective project management techniques for ensuring your study • Understanding implications for current and future development of targeted drugs runs smoothly Shanna Stopatschinskaja, Global Medical Director Oncology, • Identifying special considerations in terms of research and development, regulatory approval and commercial aspects Schering Plough Christiane Langer, Group Medical Director, Oncology Clinical 12:20 Networking Lunch Break Research Europe, Bristol Myers Squibb 13:30 Effective internal and external partnerships in oncology trials EFFECTIVE APPLICATION OF BIOMARKERS FOR A BETTER UNDERSTANDING OF PATIENT OUTCOMES • Optimal outsourcing strategies to safeguard the trial design and aims of the study 17:05 Validating biomarkers in oncology drug development • Solutions for cutting costs without compromising drug development • The use of biomarkers in clinical studies to develop novel cancer therapies activities • Utilising biomarkers in early clinical drug development to identify trial • Identifying expertise and finding the right trial external partners to fit errors early the needs of the trial • Techniques to generate accurate decision-making data • Making the matrix work for cross-functional teams involved in drug • Increasing drug development predictability using biomarkers development Michael Shi, Director, Biomarker Project Leader, Exploratory Oncology • Project management and monitoring to minimise delays and cost overruns Department, Novartis Ridwaan Jhetam, Global Clinical Operations Head: Oncology Senior Director, Johnson and Johnson 17:45 Chairperson’s Closing Remarks and Close of Day Two
  • 5. WHO SHOULD ATTEND > Directors, senior managers and managers from the following areas within pharmaceutical manufacturers and biotechcompanieswith responsibility for: • Oncology • Clinical researchand development • Clinical trials • Clinical operations • Medical affairs • Drug development • Pharmacokinetics and dynamics • Biomarkers • Imaging Directors and researchers from oncology-focused institutes and research organisations involved in: • Oncology • Clinical research and development • Clinical trials • Clinical operations Sponsorship Opportunities Why Now? Optimising Clinical Development in Oncology Between 2000 and 2020, the World Health Organization has will be attended by senior officials and decision- predicted a 50% rise in the global incidence of cancer. To keep makers from industry worldwide, bringing pace with the health needs of the growing number of young and together buyers and suppliers in one location. old afflicted with cancer globally, clinical development in Focused and high-level, the event will be an oncology is one of the fastest growing areas within the Pharma excellent platform to initiate new business industry. The market is now valued at $55 billion and is forecast relationships. With tailored networking, to increase to $78 billion by 2012. sponsors can achieve the face-to-face contact that overcrowded trade shows cannot deliver. Pharma and biotech companies are under pressure to find Exhibiting and sponsorship options are innovative ways of speeding development times in order to extensive, and packages can be tailor-made to claim their share of this lucrative area. However, oncology suit your individual company's needs. poses unique patient recruitment, trial design and operational challenges – issues that can waste invaluable resource and slow For more information please contact regulatory approval. sponsorship on +44 (0)207 368 9300 or email sponsorship@iqpc.com What Does Pharma IQ’s Optimising Clinical Development in Oncology offer? This conference provides a unique platform for drug developers to discuss practical, proven ideas to save time and money and ensure that companies have the knowledge they need to take their drugs to market fast. This case study driven agenda will help you uncover ways to make the incremental improvements to your clinical trials that can greatly reduce the time it takes to get your treatments to market. www.OncologySummit.co.uk
  • 6. OPTIMISING CLINICAL DEVELOPMENTIN ONCOLOGY 2-Day Conference: 27th – 28th April 2010 Pre-Conference Workshop Day: 26th April 2010 Venue: Le Meridien, Piccadilly, London, United Kingdom REGISTRATION FORM 5 WAYS TO REGISTER To speed registration, please provide the priority code located on the mailing label or in the box below. Freephone: 0800 652 2363 or +44 (0)20 7368 9300 My registration code is PDFW Please contact our database manager on +44(0) 207 368 9300 or at database@iqpc.co.uk quoting the registration code above to inform us of any changes or to Fax: +44 (0)20 7368 9301 remove your details. Post: your booking form to IQPC Ltd. Anchor House, 15-19 Britten Street,London SW3 3QL Online: www.oncologysummit.co.uk Email: enquire@iqpc.co.uk TEAM DISCOUNTS* TEAM 3DISCOUNTS* of 5 receive 15% off, Teams of 7 Teams of receive 10% off, Teams receive 20% off Team discounts are only available on standard pricing packages and there is only one discount available per person booking at CONFERENCE PACKAGES the same time from the same company Register and pay by Register and pay by Register and pay by Standard Price PACKAGES (Please Tick Box) 18 December 2009* 29 January 2010* 19 February 2010* Platinum Package VENUE AND ACCOMMODATION Conference + 2 Workshops + Full SAVE £500 SAVE £400 SAVE £300 Access to Conference Recordings £2,496 + VAT £2,596 + VAT £2,696 + VAT £2,996 + VAT VENUE: Gold Package*** Le Meridien Piccadilly Conference + 1 Workshop + Full SAVE £400 SAVE £300 SAVE £200 Access to Conference Recordings £2,097 + VAT £2,197 + VAT £2,297 + VAT £2,497 + VAT 21 Piccadilly Silver Package SAVE £400 SAVE £300 SAVE £200 London W1J 0BH Conference + 2 Workshops £2,097 + VAT £2,197 + VAT £2,297 + VAT £2,497 + VAT Phone: (44)(20) 7734 8000 Bronze Package*** SAVE £300 SAVE £200 SAVE £100 Conference + 1 Workshop £1,698 + VAT £1,798 + VAT £1,898 + VAT £1,998 + VAT ACCOMMODATION: Conference Only SAVE £200 SAVE £100 Accommodation is not included in the registration fee. For Le Meridien £1,299 + VAT £1,399 + VAT £1,499 + VAT £1,499 + VAT Piccadilly Tel: 0207 851 3344. Always quote GA1 or book online at Workshop Only*** (Half Day) £499 + VAT £499 + VAT £499 + VAT £499 + VAT www.lemeridien.com/ga1. Prices range from £200 + vat for the room only. *To qualify for discounts, payment must be received with bookings by the early registration deadline. Early booking discounts are not valid in For further hotels search: www.4cityhotels.com conjunction with any other offer. All above prices are subject VAT at 17.5%. VAT Reg# GB 799 2259 67 ** Academic Rate/Small Biotech: If you are an academic or work for a small biotech with between 2 and 100 people, you qualify for a 50% discount. FREE ONLINE RESOURCES ***Please choose workshops: WORKSHOP A WORKSHOP B To claim a variety of articles, podcasts and other free resources please visit www.oncologysummit.co.uk DELEGATE DETAILS Please photocopy for each additional delegate TERMS AND CONDITIONS DELEGATE 1 PAYMENT TERMS Payment is due in full upon completion and return of the Mr Mrs Miss Ms Dr Other First Name registration form. Due to limited conference space we advise early Family Name Department registration and payment by credit card to avoid disappointment. Your Position Tel No. registration will not be confirmed until payment is received. Admission to the Email conference will be refused if payment has not been received. Payment of Yes I would like to receive information about products and services via email invoices by means other than credit card, or purchase order (UK Plc and Organisation Government bodies only) will be subject to a £49 (plus VAT) processing fee. 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