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2nd Annual Bioequivalence and Bioavailability Studies 2011 - Agenda
2nd Annual Bioequivalence and Bioavailability Studies 2011 - Agenda
2nd Annual Bioequivalence and Bioavailability Studies 2011 - Agenda
2nd Annual Bioequivalence and Bioavailability Studies 2011 - Agenda
2nd Annual Bioequivalence and Bioavailability Studies 2011 - Agenda
2nd Annual Bioequivalence and Bioavailability Studies 2011 - Agenda
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2nd Annual Bioequivalence and Bioavailability Studies 2011 - Agenda

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2nd Annual Bioequivalence and Bioavailability Studies - Full Agenda …

2nd Annual Bioequivalence and Bioavailability Studies - Full Agenda

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  1. presents the 2nd Annual Register and pay before 24th June and save up to €450 Bioequivalence BioavailabilityStudies Two Day Conference: 20th – 21st September 2011 & Pre-Conference Workshop Day: 19th September 2011 Location: Four Points by Sheraton, Brussels, BelgiumSpeed time to market by ensuring regulatory compliance, biowaiver approvaland successful bioequivalence studies for modified release productsThe only event in Europe that will help you to: Don’t miss the opportunity to engage with top European Explore strategies to ensure compliance and speed time to regulators including: market: Tamás Paál, National Institute for Pharmacy Christoph Baumgärtel, Head of Department, Directorate and Kevan Cassidy, Rosemont Pharmaceuticals Safety and Efficacy Assessment of Human discuss the EMA bioequivalence guidelines one year on Medicinal Products, AGES, Austria Save development time and speed approval through successful Tamás Paál, Senior Advisor, National Institute for Pharmacy Directorate, biowaiver applications, gain expert guidance from Ivana Hungary Taševská, State Institute for Drug Control Marcus Savsek, Pharmaceutical Assessor, Ensure you have the correct strategies in place to comply BfArM, Germany with the draft modified release guidelines: unravel the key Ivana Taševská, Pharmaceutical Assessor, Department of Pharmaceutical Evaluation, changes and the implications for industry with Christoph State Institute for Drug Control, Baumgärtel, AGES Czech Republic Implement effective modelling and simulation tools to translate Along with a wealth of industry bioequivalence results into clinical relevance with an exclusive case case studies, including: study from Thomas Kerbusch, Merck/MSD Marcus Brewster, Distinguished Research Perfect your comparative study design to ensure first time Fellow, Pharmaceutical Research, Johnson & Johnson, Belgium approval with expert advice from Sandra van Os, Synthon Kevan Cassidy, Clinical Director, Rosemont Pharmaceuticals, UK & Co-chair, EGA Pre-Conference Workshop Day: 19th September Bioequivalence Working Group Don’t miss out on our interactive pre-conference workshop day – these workshops Jiri Hofmann, Clinical Development Manager, represent a unique opportunity to discover essential solutions to establishing the Zentiva, Sanofi-Aventis Group, optimal solubilising delivery techniques, gain expert advice on using biowaivers in Czech Republic practice and understanding biostatistical relevance of variability in 2 stage Thomas Kerbusch, Senior Director approaches. Engage in hands-on practical sessions led by: (Technical Lead Innovation, Implementation & Marcus Brewster, Distinguished Jean-Michel Cardot, Department Impact of M&S), Merck, Sharp & Dohme, Research Fellow, Pharmaceutical of Biopharmaceutics and the Netherlands Research, Johnson & Johnson, Pharmaceutical Technology, Belgium University d’Auvergne, France Filippos Kesisoglou, Research Fellow, Merck & Co, US Anders Fuglsang, Consultant, Helmut Shütz, CEO, FuglsangPharma, Germany BEBAC, Austria Sandra van Os, Head of Clinical Operations, Synthon BV, the Netherlands Vit Perlik, Senior Clinical Development Interactive Formats: get involved in our lively regulatory panel Manager, Zentiva, Sanofi-Aventis Group, discussion, get down to the root of the problem with our focused Czech Republic roundtable sessions and learn what is really happening from your Jean-Michel Cardot, Department of peers during our extended networking session Biopharmaceutics and Pharmaceutical Technology, Université d’Auvergne, France Anders Fuglsang, Consultant, What past attendees have said about this event: Fuglsang Pharma, Denmark “Very good to hear the assessors views on the matter.” Abbott Helmut Schütz, Director, BEBAC, Austria +44 (0)20 7368 9300 www.bioequivalenceevent.com ENQUIRE@IQPC.CO.UK
  2. Pre-Conference Workshop Day Monday 19th September 2011 Maximising the Efficiency of Bioequivalence & Bioavailability Studies through Biowaiver Applications, Improved Drug Delivery Systems and Bioanalytical Guidance Setting up a BE study: from design to approval By attending this workshop, participants will discover how to successfully plan and perform bioequivalence studies. You will come away with a greater understanding of:A • The history of bioequivalence testing: lessons from the past which have influenced modern-day studies • Current bioequivalence study strategies: which study design and when? • The role of noncompartmental analysis (NCA) in pharmacokinetics and PK-based study design • Best practice in statistical design and analysis Helmut Schütz, CEO, BEBAC, Austria 10.30 – 13.30 Approaches for drug solubilisation By attending this interactive workshop, participants will gain in-depth insights into the aspects of formulating poorly water-soluble drug candidates and the use of solubilising drug delivery technologies. You will come away with expert guidance on: • Preformulation approaches for determining the extent of enablement needed to engender useful oral bioavailability for a poorly soluble drug candidateB • Assays to provide information on drug candidate biopharmaceutical fitness • Decision trees on solubilising technique and where they add the most value for both new compounds as well as life-cycle management opportunities • Overview of currently marketed solubilising drug delivery systems including but not limited to the use of cyclodextrins, nanosuspension and related dosage forms and solid dispersions • Hybrid technologies and drug-device combinations for poorly water-soluble drugs • Developmental considerations including impacts on cost, quality and cycle time • Potential technologies that may impact future applications and horizon-scanning approaches Marcus Brewster, Distinguished Research Fellow, Pharmaceutical Research, Johnson & Johnson, Belgium 10.30 – 13.30 Power and intra-subject variability in 2 stage approaches to bioequivalence approvalC Details to be released shortly. Visit www.bioequivalenceevent.com for further updates. Helmut Schütz, CEO, BEBAC, Austria & Anders Fuglsang, Consultant, FuglsangPharma, Germany 14.30 – 17.30 Biowaivers in practice: understanding the practicalities of biowaivers and harnessing their time and cost saving benefits By attending this hands-on workshop, participants will identify and overcome the obstacles to securing a biowaiver. You will come away with further clarification on:D • What a biowaiver is • Differences between biowaivers and surrogates of in vivo studies • Types of biowaivers • Practical applications - In drug development - For generics - BCS biowaivers - Limitations of biowaivers - IVIVC based biowaivers • Legal points in the EU and US Jean-Michel Cardot, Department of Biopharmaceutics and Pharmaceutical Technology, University d’Auvergne, France 14.30 – 17.30 +44 (0)20 7368 9300 www.bioequivalenceevent.com ENQUIRE@IQPC.CO.UK
  3. Conference Day 1 Tuesday 20th September 201108.15 Registration and Coffee 14.20 The role of BCS in drug development programmes • Use of BCS, DCS and BCDDS in compound selection and early testing09.00 Pharma IQ’s Welcome and Opening Remarks from Chairperson CASE • Biopharmaceutical assessments and BCS GETTING TO GRIPS WITH THE BIOEQUIVALENCE STUDY • Expert case studies showcasing successful use of BCS in GUIDELINES TO ENSURE FIRST TIME APPROVAL drug development09.10 Industry experience with the EMA bioequivalence guideline Marcus Brewster, Distinguished Research Fellow, • Has the bar for generic entry been raised? Pharmaceutical Research, Johnson & Johnson, BelgiumCASE • Practical examples of successful use of the updated guidelines 15.00 Networking Refreshment BreakSTUDY • The industry wish-list: highlighting the opportunities and limitations of the guidelines and what industry wants to see in the future 15.30 REGULATORY PANEL DISCUSSION: Your chance to ask all of your crucial questions and get the answers you need. INTERACTIVE Kevan Cassidy, Clinical Director, Rosemont Pharmaceuticals, UK & Co-Chair, EGA Bioequivalence Working Group In this session, participants will have the opportunity to ask regulators specific questions about guidance including compliance issues,09.50 The new EMA bioequivalence guideline one year on: biowaiver applications, FDA guidelines, bioanalysis and modified release a regulatory perspective products. The panel will address the key regulatory considerations,REGULATOR • Clearing the confusion: key areas of misunderstanding practical approaches and time saving solutions to planning, conducting • Useful strategies to ensure compliance and speed time to market and submitting your studies. • Ensuring drug safety: CMD(h) referrals in 2010 Tamás Paál, Senior Advisor, National Institute for Pharmacy Tamás Paál, Senior Advisor, National Institute for Pharmacy Directorate, Hungary Directorate, Hungary Marcus Savsek, Pharmaceutical Assessor, BfArM, Germany10.30 Extended Networking & Refreshments Ivana Taševská, Pharmaceutical Assessor, Department of Bring plenty of business cards to exchange in a series of one-on-one Pharmaceutical Evaluation, State Institute for Drug Control,INTERACTIVE meetings with your fellow attendees. Your mission - discuss one of the Czech Republic following things with each person you meet: ASSESSING AND EVALUATING THE ROLE OF IVIVC 1. Biggest challenge in bioequivalence testing IN BIOEQUIVALENCE 2. Outsourcing strategies: choosing your CRO 3. Biowaiver success stories 16.10 Application of IVIVC to bioequivalence testing • Reducing time and money: predicting bioequivalence from in vitro11.20 An overview of the EU guideline on the validation of dissolution tests bioanalytical methods • Internal versus external validation of IVIVC: ensuring success ofREGULATOR • Understanding the differences between the EU and US your model • Highlighting the typical areas of non-compliance and strategies • Role of IVIVC in generic drug product development and approval to avoid these pitfalls Jean-Michel Cardot, Department of Biopharmaceutics and • Integration with the principles of GLP Pharmaceutical Technology, University d’Auvergne, France • Lessons from Crystal City: how to handle incurred sample reanalysis Marcus Savsek, Pharmaceutical Assessor, BfArM, Germany 16.50 Closing Remarks from Chairperson and End of Day One SUCCESSFULLy IMPLEMENTING QBD12.00 PANEL DISCUSSION: Applying Quality by Design principles to BE/BA studies In this session, participants will have the opportunity to ask specific questions regarding the application of QbD to BE/BA studies. The panel will address key issues including: Does quality by design add value to BE/BA studies? How to identifying and overcome the specific issues of applying QbD to biogeneric drug development, how to successfully implement quality by design and achieve optimal results12.40 Networking Lunch EFFECTIVE APROACHES TO BIOWAIVER SUCCESS13.40 Tips from the regulators for successfully securing a biowaiver What others have said • Interpreting the guideline and understanding the approval process about Pharma IQ events:REGULATOR to maximise biowaiver application success • Successful use of analytical methods to secure a biowaiver “Great mix of presenters • Improving first time approval: understanding what is and what isn’t eligible covering a comprehensive Ivana Taševská, Pharmaceutical Assessor, Department of Pharmaceutical Evaluation, State Institute for Drug Control, range of topics-well done. Czech Republic Superb networking opportunity.” Pfizer +44 (0)20 7368 9300 www.bioequivalenceevent.com ENQUIRE@IQPC.CO.UK
  4. Conference Day 2 Wednesday 21st September 201108.15 Registration and Coffee C) Dealing with combination and highly variable products In a market where drug development is moving further away from simple08.50 Pharma IQ’s Welcome and Opening Remarks from Chairperson compounds, this session provides an opportunity to evaluate the INVESTIGATING BEST PRACTICE IN STUDy DESIGN challenges of developing combination and highly variable products. TO SPEED TIME TO MARKET Topics for discussion include: further clarification of the EU and US stance on scaling, why do we worry about outliers? Justification of fixed09.00 Perfecting the two stage study design dose combinations (FDC) and current thinking on data exclusivity of FDC • What are the benefits of using a two stage design? Vit Perlik, Senior Clinical Development Manager, & Jiri Hofmann, • Successfully controlling type 1 error rate Clinical Development Manager, Zentiva, Sanofi-Aventis Group, • Challenges and solutions for determining optimal sample size Czech Republic • Replicate designs: can they be combined with two stage designs? • Case examples of two stage studies 12.50 Networking Lunch Helmut Schütz, CEO, BEBAC, Austria 13.50 Challenges in the design of comparative bioavailability studies:09.40 Bioequivalence approaches to highly variable drugs and experiences from industry highly variable drug products CASE • Parent drug or metabolite? • Reference scaling versus widening of the confidence intervals STUDY • Cross over or parallel design? • EMA position on the evaluation of replicate studies • Patients vs. volunteers? • Dealing with outliers: use of outlier checks and understanding - High variability when and why outliers should be excluded - Pilot studies Jiri Hofmann, Clinical Development Manager, Zentiva, Sanofi-Aventis Sandra van Os, Head of Clinical Operations, Synthon BV, Group, Czech Republic the Netherlands10.20 Networking Refreshment Break EFFECTIVE MODELLING, SIMULATION AND DISSOLUTION TOOLS TO ESTABLISH BIOEQUIVALENCE10.50 Seeking approval for nasal hybrids/generics: don’t try this at home! 14.30 Translating (non-) bioequivalence results to clinical (IR) • Regulatory situation in EU and US relevance through integrated modelling and simulation of • Relevance of a stepwise approach to approval in EU CASE PK/PD- efficacy/safety • Pitfalls associated with PK and PD evaluations STUDY • Regulatory aspects of modelling and simulation Anders Fuglsang, Consultant, FuglsangPharma, Germany • Models to link pharmacokinetics to pharmacodynamics to efficacy and safety11.30 Combination products: why do we combine and what are the • Simulating clinical relevance of PK findings implications for bioequivalence studies? • Leveraging competitor dataCASE • Understanding the legal frameworkSTUDY • Examples from industry • Fixed dose combinations – space for innovation? Thomas Kerbusch, Senior Director, Technical Lead Innovation, • Examples of clinical development strategies for combination products Implementation & Impact of Modeling & Simulation, Merck/MSD, Vit Perlik, Senior Clinical Development Manager, Zentiva, the Netherlands Sanofi-Aventis Group, Czech Republic 15.10 Networking Refreshment Break12.10 BREAKOUT ROUNDTABLE DISCUSSIONS: Participants will be able to choose one of the roundtables outlined 15.40 Optimising dissolution testing below and spend 40 minutes discussing the points: • Modelling and simulation approaches to determine dissolution rates • Assessing impact of dissolution on bioavailability A) Regulatory expectations and submission criteria • Moving from dissolution studies to BE/BA studies Delegates will have the opportunity to discuss challenges and solutions Filippos Kesisoglou, Research Fellow, Merck & Co, US for maximising biowaiver success directly with the regulators. Topics discussed will include: where, when and how to apply for a ENSURING EFFECTIVE BIOEQUIVALENCE STUDIES FOR biowaiver, regulatory expectations, submission criteria, examples of MODIFIED RELEASE PRODUCTS successes and failures. 16.20 Development of modified release guidelines Ivana Taševská, Pharmaceutical Assessor, Department of • Overview of current guidelines REGULATOR Pharmaceutical Evaluation, State Institute for Drug Control, • Understanding the key changes and what it will mean for industry Czech Republic • Regulatory expectations and submission criteria B) Simulating dissolution profiles Christoph Baumgärtel, Head of Department, Safety and Efficacy This discussion will examine the latest modelling and simulation tools Assessment of Human Medicinal Products, AGES, Austria and provide practical advice on how to use the generated profiles to 17.00 Closing Remarks from Chairperson and End of Conference establish bioequivalence in vitro. Topics discussed will include: the role of simulation in determining IVIVC, integrating dissolution profiles into development strategies and examples of successes and failures. Filippos Kesisoglou, Research Fellow, Merck & Co, US +44 (0)20 7368 9300 www.bioequivalenceevent.com ENQUIRE@IQPC.CO.UK
  5. About the Event TOP 10 REASONS TO ATTEND 1. Receive regulatory clarification of the bioequivalence 6. Overcome the challenges of establishing bioequivalence submission criteria to ensure compliance and speed for highly variable drugs time to market 7. Address the implications for industry of the draft 2. Be prepared for the new modified release guidelines bioanalytical guidelines 3. Make informed decisions before starting your studies 8. Translate results to clinical relevance using modelling and through effective use of in vitro testing and establishing IVIVC stimulation tools 4. Optimise study design by understanding the two stage approach 9. Interactive roundtable sessions - gain further in-depth knowledge in your chosen subject area 5. Successfully secure a biowaiver with tips from the regulators and clarification of the biopharmaceutical classification system 10. Interact and network with your colleagues and peers in our dedicated networking sessions! Media partnersWho Should Attend • • Clinical Pharmacology PKPD • • Analytical Science Analytical R&DDirectors, senior managers and managers within • Clinical Development • Regulatory Affairspharmaceutical manufacturers, biotech and generics • Clinical Operations • Principal and Senior Scientistscompanies and academic institutes with responsibility for: • Pre/Formulation Maximise your Involvement: Sponsorship and Exhibition Opportunities The Pharma IQ Bioequivalence and Bioavailability Studies conferenceAbout Pharma IQ will be the perfect platform for service providers to meet senior-Continue your learning experience with Pharma IQ online. As level decision makers in the pharmaceutical/biopharmaceuticalwell as playing host to a series of global events where leading and generics industry who are looking for solutions and servicesindustry experts and thought leaders share their experience, to improve efficiency of bioequivalence and bioavailability testing.knowledge and strategic thoughts, Pharma IQ also offers an Contact Pharma IQ to discuss how to position your company inonline community for pharma & biotech professionals. Join now front of your participants who are keen to learn more about today’sto network with your peers and access exclusive videos, podcasts technologies and services including Merck/MSD, Synthon BV,and presentations from this and other Pharma IQ events. Rosemont Pharmaceuticals, Johnson & Johnson, Zentiva and many more. For more information on the sponsorship opportunitiesJoin the community: http://Pharma-IQ.com/join.cfm available please email sponsorship@iqpc.co.uk or phone +44 (0) 207 368 9300. +44 (0)20 7368 9300 www.bioequivalenceevent.com ENQUIRE@IQPC.CO.UK
  6. Bioequivalence BioavailabilityStudies & 5 Ways to Register Freephone: 0800 652 2363 or +44 (0)20 7368 9300 Two Day Conference: 20th – 21st September 2011 Pre-Conference Workshop Day: 19th September 2011 Fax: +44 (0)20 7368 9301 Location: Four Points by Sheraton. Brussels, Belgium To speed registration, please provide the priority code located on the mailing label or in the box below. Post: your booking form to IQPC, 129 Wilton Road, My registration code pdfw Victoria, London, Please contact our database manager on +44(0) 207 368 9300 or at database@iqpc.co.uk quoting the SW1 V1JZ registration code above to inform us of any changes or to remove your details. Email: enquire@iqpc.co.uk Book and Pay Before Book and Pay Before Book and Pay Before 24th June* 29th July* 9th September* Standard Price www.bioequivalenceevent.com conference + 2 Workshops** + Full Access €3,297+VAT €3,347+VAT €3,447+VAT €3,747+VAT to conference Recordings Save €450 Save €400 Save €300 conference + 1 Workshop** €2,748+VAT €2,798+VAT €2,898+VAT Team Discounts* + Full Access to conference €3,098+VAT Save €350 Save €300 Save €200 Recordings IQPC recognises the value of learning in teams. Groups of 3 or more booking at the same time from the same company receive a 10% discount. 5 or more receive a conference + 2 €2,797+VAT €2,847+VAT €2,947+VAT Workshops** Save €400 Save €350 Save €250 €3,197+VAT 15% discount. 7 receive a 20% discount. Only one discount available per person. €2,248+VAT €2,298+VAT €2,398+VAT conference + 1 Workshop** Save €300 Save €250 Save €150 €2,548+VAT Venue & Accommodation conference only €1699+VAT €1,749+VAT €1,899+VAT €1,899+VAT VENUE: Four Points by Sheraton Save €200 Save €150 Rue Paul Spaak 15, Brussels, 1000, Belgium, Tel: + 32 2 645 6111 Audio recordings €550+VAT €550+VAT €550+VAT €550+VAT AccoMMoDAtIoN: Travel and accommodation are not included in the registra- (cD/erb access) tion fee, however a number of discounted bedrooms have been reserved at the Four Points Hotel. Please call the hotel directly on Tel: + Tel: 32 2 645 6111 and * To qualify for discounts, payments must be received by the early bird registration deadline. Early booking discounts are not quote booking reference IQPC to receive your discounted rate, prices start from valid in conjunction with any other offer. €160 including taxes and breakfast. There is limited availability so we do encour- ** Please select your choice of workshop A or B and C or D age attendees to book early to avoid disappointment. Alternatively for a further Belgian VAT charged at 21%. Belgian VAT Registration BE 081 7979 521 selection of hotels, please visit: www.4cityhotels.com/brussels.html Free Online Resources To claim a variety of articles, podcasts and other free resources please visit Join our event listing on Linked In www.bioequivalenceevent.com http://events.linkedin.com/2nd-Annual-Bioequivalence/pub/680993 Digital Conference On CD-ROM Delegate Details A digital version of the conference proceedings, including all presentations, Please photocopy for each additional delegate is available to buy. 6 Mr 6 Mrs 6 Miss 6 Ms 6 Dr 6 Other 6 I cannot attend the event, please send me the CD Rom priced at £599 plus VAT Recent digital conferences available - £599 plus VAT each First Name Family Name 6 GCOF Job Title 6 Oncology Clinical Trials Tel No. 6 Compound Management Email 6 Improving Solubility for Pharmaceuticals and Biologics 6 Yes I would like to receive information about products and services via email 6 Polymorphism and Crystallisation Organisation 6 Clinically Relevant Drug Transporters Nature of business 6 Pharmaceutical Co-Crystals 2010 Address 6 Amorphous Pharmaceutical Materials 2010 Postcode Country 6 Please send me conference materials indicated above Telephone Fax 6 I have filled out credit card details below For further information Please call: 0207 368 9300 or email: knowledgebank@iqpc.co.uk Approving Manager To search IQPC’s archived conference documentation visit: www.iqpcknowledgebank.com Name of person completing form if different from delegate: Signature Terms and Conditions Please read the information listed below as each booking is subject to IQPC Ltd standard terms and I agree to IQPC’s cancellation, substitution and payment terms conditions. Payment terms: Upon completion and return of the registration form, full payment is Special dietary requirements: 6 Vegetarian 6 Non-dairy 6 Other (please specify) required no later than 5 business days from the date of invoice. Payment of invoices by means other Please indicate if you have already registered by Phone 6 Fax 6 Email 6 Web 6 than by credit card, or purchase order (UK Plc and UK government bodies only) will be subject to a €65 (plus VAT) per delegate processing fee. Payment must be received prior to the conference date. Please note: if you have not received an acknowledgement before the conference, please call us to confirm your booking. We reserve the right to refuse admission to the conference if payment has not been received. IQPc cancellation, Postponement and Substitution Policy: You may substitute delegates at any time by providing reasonable advance notice to IQPC. For any cancellations received in writing not Payment Method less than eight (8) days prior to the conference, you will receive a 90% credit to be used at another IQPC conference which must occur within one year from the date of issuance of such credit. An Total price for your Organisation: (Add total of all individuals attending): administration fee of 10% of the contract fee will be retained by IQPC for all permitted cancellations. No credit will be issued for any cancellations occurring within seven (7) days (inclusive) of the Card Number: VISA 6 M/C 6 AMEX 6 conference. In the event that IQPC cancels an event for any reason, you will receive a credit for 100% of the contract fee paid. You may use this credit for another IQPC event to be mutually 6666666666666666 agreed with IQPC, which must occur within one year from the date of cancellation. In the event thatConference code 19113.002 IQPC postpones an event for any reason and the delegate is unable or unwilling to attend in on the Exp. Date: 6 6 6 6 Sec: 6 6 6 6 rescheduled date, you will receive a credit for 100% of the contract fee paid. You may use this credit for another IQPC event to be mutually agreed with IQPC, which must occur within one year from the date of postponement. Except as specified above, no credits will be issued for cancellations. There Name On Card: Signature: are no refunds given under any circumstances. IQPC is not responsible for any loss or damage as a result of a substitution, alteration or cancellation/postponement of an event. IQPC shall assume no liability whatsoever in the event this conference is cancelled, rescheduled or postponed due to a Billing Address (if different from below): fortuitous event, Act of God, unforeseen occurrence or any other event that renders performance of this conference impracticable, illegal or impossible. For purposes of this clause, a fortuitous event shall include, but not be limited to: war, fire, labour strike, extreme weather or other emergency. City/County/Postcode Cheque enclosed for: € (Made payable to IQPC Ltd.) Please note that while speakers and topics were confirmed at the time of publishing, circumstances beyond the control of the organizers may necessitate substitutions, alterations or cancellations of the speakers and/or topics. As such, IQPC reserves the right to alter or modify the advertised speakers (Please quote 19113.002 with remittance advice) and/or topics if necessary without any liability to you whatsoever. Any substitutions or alterations IQPC Bank details: HSBC Bank, 67 George Street, Richmond, Surrey, TW9 1HG. United Kingdom. will be updated on our web page as soon as possible. Discounts: All ‘Early Bird’ Discounts require payment at time of registration and before the cut-off date in order to receive any discount. Any Sort Code: 40 05 15, Account No: 59090618, IBAN Code: GB98 MIDL 4005 1559 0906 18 discounts offered whether by IQPC (including team discounts) must also require payment at the time Swift Code: MIDLGB22 Account name: International Quality & Productivity Centre Ltd. of registration. All discount offers cannot be combined with any other offer. PAYMENT MUST BE RECEIVED PRIOR TO THE CONFERENCE

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