Regulatory Information Management


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This is the agenda and brochure for Pharma IQ's upcoming Regulatory Information Management conference on the 2nd and 3rd of March in London.
This conference is the only event of its kind to focus solely on the management of information within pharmaceutical companies, to aid regulatory submissions. The event will bring together leading professionals to focus on the regulatory aspects of data and information management.

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Regulatory Information Management

  1. 1. “The First Event of It’s Kind” Q i d e ce i s c Sl re d uo sh ive o Presents 10 te ar a un Pharmaceutical % ‘R e’ IM to Regulatory t Information Management MAIN CONFERENCE: 2nD - 3RD MARCH 2011 | PRE-CONFERENCE WORKSHOP DAY: 1St MARCH 2011 | VENUE: MAyFAIR COnFEREnCE CEntRE, LOnDOn Ensure Regulatory Compliance and Successful Distinguished Submissions Through Implementing Effective speakers include: Data Management Strategies and Solutions Alastair Nixon, Director, Submission Publishing, GlaxoSmithKline Key reasons to attend: Kevin O’Connell, Head of Dossier Management, Global Regulatory Affairs, Reduce new drug development times by UCB Pharma implementing a centralised data storage system: Remco Munnik, Regulatory Affairs Discuss which system is right for your business needs Information Manager, Sandoz David Wheeler, Former Business Relations Ensure compliance with external submission Manager, MHRA standards, to ensure successful submissions first time Mickel Hedemand, Internal Advisor, Licensing Division, Danish Medicines Increase your product revenue by reducing time to Agency market with a streamlined submissions process Helle Ainsworth, Head of Section, Submission Management, Lundbeck Understand the importance of data centralization and how to roll out a centralised strategy Morwenna Gould, Managing Director, Morphiris Hear practical case studies on e-submissions to keep Elizabeth Bricard, Submission up to date with the latest developments in validation Management & Customer Liaison, Global and harmonisation with the growing number of Regulatory Operations, Sanofi Aventis electronic submissions across the industry Susan Genseberger, Head of Global Regulatory Affairs Operations, Abbott Improve strategic organisation of submissions in Healthcare emerging markets and large multi-site submissions Anna Harrington, Director Global Regulatory Affairs APJEM Russia/CIS Country Top organisations represented: Expert, GlaxoSmithKline 1. GlaxoSmithKline 5. Danish Medicines Agency Yann Kervevan, EMEA Regulatory 2. UCB Pharma 6. Lundbeck Affairs Operations Manager, Alexion 3. Sanofi Aventis 7. Alexion Pharmaceuticals Pharmaceuticals 4. Sandoz 8. Abbott Healthcare Eldin Rammell, Managing Director, Rammell Consulting Event will discuss: John Farrell, Programme Manager, ISI • Changing submission standards and the impact on pharmaceutical companies • Regulatory expectations within eCTD and submission standards Pierre Géruzet, Worldwide Regulatory • Practical examples of risk- based validation of submission management • Setting up and maintaining a global regulatory data management system Affairs, Regulatory Operations Manager, • Coordinating global submissions in current and emerging markets GlaxoSmithKline Biologicals • Migrating the backlog of paper to an online electronic format Alastair Scarlett, Regulatory Operations Project Manager, UCB Pharma SPOnSOR: MEDIA PARtnERS: +44 (0)20 7368 9300 +44 (0)20 7368 9301 ENQUIRE@IQPC.CO.UK
  2. 2. Conference Day One: 2nd March 2011 8:30 Registration 14.10 Break-Out Round Table Discussions: Participants will be able to take part in each of the discussion groups in any 9:00 Pharma IQ Welcome and Chairperson’s order they choose. Each group will spend 20 minutes Opening Address addressing the topic, sharing ideas, solutions and David Wheeler, Former Business Relations Manager, MHRA good practice. EVOLUTION OF REGULATORY STANDARDS Roundtable A How to Set Up Templates in Order to Make your 9:10 Where are e-Submissions Going? Electronic Submission Work • mprovement in standards – eCTD NMV, NeeS I This discussion focuses on preparation and practical • Improvement in validation – checking tools and planning challenges for submissions with guidance more relevant parameters from a regulatory perspective • Improvement in processes – increased efficiency via Chair: Mickel Hedemand, Internal Advisor, Licensing Division, the CESP (Common European Submission Platform) Danish Medicines Agency David Wheeler, Former Business Relations Manager, MHRA Roundtable B 9:50 Changing Submission Standards and the Impact Dossier Review and Compilation: Assessment of on Pharmaceutical Companies Submission Documents for Content and Presentation • verview of how regulatory submissions standards O This discussion focuses on the assessment of trial have changed in recent years documents for content and presentation and compilation • Building your global strategy to incorporate the of documents into approved formats latest submission standard changes Chair: Elizabeth Bricard, Submission Management & • Outlining common problem areas when adapting Customer Liaison, Global Regulatory Operations, Sanofi Aventis to new regulatory submissions • Diversity of approaches to e-submissions across Roundtable C countries; importance of close collaboration with Handling and Sharing Regulatory Data Within your regulatory agency an Organisation • Preparing for the next steps in the changing This discussion focuses on bringing together common regulatory landscape business process, tools and knowledge bases across an Elizabeth Bricard, Submission Management & Customer Liaison, organisation to effectively share regulatory information Global Regulatory Operations, Sanofi Aventis Chair: Remco Munnik, Regulatory Affairs Information Manager, Sandoz 10:30 Networking Coffee Break 15:10 Networking Coffee Break ENSURING THE SUCCESS OF YOUR REGULATORY SUBMISSIONS PROCESS, POLICY AND DATA HARMONISATION 11:00 Making your Submission Reach the Assessor’s Table 15.40 Setting up and Maintaining a Global Regulatory • ackground for national requirements in B Data Management System regulatory submissions • etting up a registration database S • Challenges faced by agency reception • Setting up a post authorisation submission database • Typical errors and how to avoid them (variation planning and tracking tool) • Compromises in developing standards • Ensuring data compliance Mickel Hedemand, Internal Advisor, Licensing Division, • Roll-out of database in a global organisation Danish Medicines Agency Remco Munnik, Regulatory Affairs Information Manager, Sandoz ROBUST RISK ASSESSMENT STRATEGIES SUBMISSIONS AND HARMONISATION IN EMERGING MARKETS 11:40 Spotlight on Technology This session will be hosted by a leading service and 16:20 Coordinating Global Submissions: Emerging Markets software provider of solutions for regulatory information • Strategising regulatory operations across emerging markets management. If you are a service provider and would like • Understanding local regulatory policy and environments to host this session please contact • Selecting development partners with knowledge of Luke Dash on +44 (0)201 368 9501 submissions in emerging markets Kevin O’Connell, Head of Dossier Management, 12:20 Networking Lunch Break Global Regulatory Affairs, UCB Pharma 13:30 Working with the PIM Submission Process 17:00 Status of Harmonisation with CTD Requirements • eveloping a holistic view of information exchange D within the CIS Region across the regulatory submission process • anguage requirements for CTD and submissions L • Improving information management and the quality to regional authorities of documentation with information re-use • Timelines of regulatory agencies and the • Minimising inconsistency, manual input errors, submission process repetition and delay • Developing an effective working relationship with • Available technology solutions: benefits and limitations affiliate offices in the CIS region Morwenna Gould, Managing Director, Morphiris Ltd Anna Harrington, Director Global Regulatory Affairs APJEM Russia/CIS Country Expert, GlaxoSmithKline 17:40 Chairperson’s Closing Remarks and Close of Conference Day One +44 (0)20 7368 9300 +44 (0)20 7368 9301 ENQUIRE@IQPC.CO.UK
  3. 3. Conference Day Two: 3rd March 2011 8:30 Registration 14:10 Break-Out Round Table Discussions: Participants will be able to take part in each of the discussion groups in any 9:00 Pharma IQ Welcome and Chairperson’s order they choose. Each group will spend 20 minutes Opening Address addressing the topic, sharing ideas, solutions and Mickel Hedemand, Internal Advisor, Licensing Division, good practice. Danish Medicines Agency Roundtable A OPTIMISING REGULATORY SUBMISSIONS Strategies Towards Gaining Market Access Through Successful Submissions 9:10 Effective Planning for Submissions This discussion provides the opportunity to explore how to • dentifying planning needs I ensure a robust and successful submissions strategy that • Implementing databases can enhance a brand profile in existing and emerging markets • Bringing together common business process, Chair: Alastair Nixon, Director, Submission Publishing, tools and knowledge bases GlaxoSmithKline • Establishing processes for knowledge transfer to facilitate submissions Roundtable B Susan Genseberger, Head of Global Regulatory Affairs Major Challenges in Changing from the Paper Operations, Abbott Healthcare World to the Electronic World This discussion highlights solutions to the practical 9:50 Harmonisation of eCTD and Nees Validation Criteria obstacles in migrating from traditional to technology • The impact of the growing number of eCTD submissions focused submission protocols and standards on the description and interpretation of the validation criteria Chair: Helle Ainsworth, Head of Section, • eCTD validation rules and consequences for Submission Management, Lundbeck future submissions • Implementation of new validation criteria Roundtable C Alastair Nixon, Director, Submission Publishing, GlaxoSmithKline Sharing Information on Regulatory Intelligence Across an Organisation 10:30 Networking Coffee Break This discussion addresses the practical challenges in disseminating regulatory intelligence and information 11:00 Making the Transition from Paper Based to amongst regulatory affairs, operations and submissions Electronic Submissions professionals in order to continuously improve awareness • oll-out and implementation of eCTD R of trends and developments • Transferring legacy products to eCTD format Chair: Susan Genseberger, Head of Global Regulatory • Ensuring company compliance and developing process Affairs Operations, Abbott Healthcare for metadata and lifecycle management • Developing submission readiness in an 15:10 Networking Coffee Break adapting environment • Overcoming the challenge of delivering REGULATORY INTELLIGENCE AND STRATEGY different submission formats Helle Ainsworth, Head of Section, Submission Management, 15:40 Panel Discussion: Improving Regulatory Lundbeck Intelligence to Optimise the Submissions Process • ollating information on current and future C 11:40 Challenges in eCTD Implementation and regulatory trends Electronic Submissions • Processing regulatory intelligence • onverting and assembling files C • Effectively sharing information on regulatory intelligence • Quality control, content and technical validation across an organisation of eCTD submissions Panellists include: • Managing submission timelines and Yann Kervevan, EMEA Regulatory Affairs Operations regulatory expectations Manager, Alexion Pharmaceuticals • Overcoming coding challenges when transferring Alastair Nixon, Director, Submission Publishing, data from eCTD to regulatory platforms GlaxoSmithKline Yann Kervevan, EMEA Regulatory Affairs Operations Manager, Kevin O’Connell, Head of Dossier Management, Alexion Pharmaceuticals Global Regulatory Affairs, UCB Pharma 12:20 Networking Lunch Break ELECTRONIC DOCUMENT MANAGEMENT RECORDS AND DATA MANAGEMENT SYSTEMS CASE STUDIES 13:30 Assessing the Pitfalls and Opportunities of 16:20 Implementation of a New eDMS for Regulatory Centralising your Data Management System Operations – The GSK Biologicals Experience • nderstanding the need to manage submissions U • Ensuring efficiency and accuracy of electronic workflow • Managing market pressures with an holistic approach • Enabling easier circulation and approval of documents to regulatory information management • Delivering time, cost, and space saving solutions, • Responding promptly and completely to regulators while maintaining data security • Developing a centralised, integrated solution to Pierre Géruzet, Worldwide Regulatory Affairs, Regulatory incorporate all aspects of the product portfolio, from Operations Manager, GlaxoSmithKline Biologicals clinical and R&D right through to resource management and planning 17:00 EDMS Management, Administration and Training John Farrell, Programme Manager, ISI • Managing information for globalisation and innovation • Document security models • Identifying and utilising the appropriate tools from available resources Alastair Scarlett, Regulatory Operations Project Manager, UCB Pharma 17:40 Chairperson’s Closing Remarks and Close of Conference Day Two +44 (0)20 7368 9300 +44 (0)20 7368 9301 ENQUIRE@IQPC.CO.UK
  4. 4. Pre-conference Workshop Day: 1st March 2011 Workshop A: Building a Robust Trial Master File (TMF) to Facilitate Regulatory Submissions 08.30 – 12.30 This workshop focuses on the theme of trial master files from a clinical operations perspective. Delegates will benefit from guidance on important challenges as they pertain to regulatory activities, in particular: • How to build a compliant TMF process • How the different needs of clinical operations and regulatory affairs can be met by a single TMF system • Process-based approach to repository metadata models Workshop host: Eldin Rammell, Managing Director, Rammell Consulting Workshop B: Managing a PIM Submission with the Light Authoring Tool (LAT) 14.00 – 17.00 This workshop is focused on supporting your application of PIM principles to regulatory submissions and developing your skills in using the Light Authoring Tool (LAT) • Creating PIM submissions • Realising the benefits of the LAT • Likely future developments in PIM For more information on how to facilitate or sponsor this workshop please contact Luke Dash at What Does Pharma IQ’s Pharmaceutical Join the Regulatory Information Management Offer? Pharma IQ community This conference provides a unique platform for drug Become a member of Pharma IQ and receive complimentary developers, national regulators and service providers to share access to resources that will keep you at the forefront of good practice and successful strategies to help get products industry change. You will receive access to our growing to market more quickly. Professionals across key functions library of multi-media presentations from industry leaders, an in regulatory affairs and operations will get to grips with the email newsletter updating you on new content that has been practical challenges of managing, sharing and submitting added, free aggregated news feed from over 1000 global regulatory information for faster, accurate and successful news sources tracking your industry and special member only submissions, across the EMEA region and in emerging markets. discounts on events. Through a mixture of case studies and strategic presentations, For more information and to become a member, this agenda will provide solutions based on a range of proven visit and successfully implemented submission and information management policies to help you enhance your current processes and overcome your regulatory hurdles. For sponsorship and exhibition opportunities contact us on +44 (0) 207 368 9300 or Current Sponsor: Media Partners: +44 (0)20 7368 9300 +44 (0)20 7368 9301 ENQUIRE@IQPC.CO.UK
  5. 5. Who Should Attend Elizabeth Bricard Over 30 years in the Pharmaceutical Industry based in France, Directors, senior managers and managers from the following starting with Roussel Uclaf through Hoechst Marion Roussel, Aventis and today Sanofi-aventis. Working in development for the last 20 areas within pharmaceutical manufacturers and biotech years with experience in Preclinical (translation and report/dossier companies, clinical researchers and service providers: management), Clinical Pharmacology (global coordination focusing mainly on studies and document management) and finally Regulatory Operations From Pharmaceutical and Biotech Manufacturers: since 2005. Involved from mid 1990s in the setting up and management of • Regulatory Affairs eDMS systems in the various organizations. Currently Submission Manager • Regulatory Data Management and Customer Liaison for European, Asia-Pacific and Intercontinental regions. • Regulatory Information Management • Regulatory Operations Remco Munnik • Information Technology Remco Munnik has a Bachelor degree in a study of Management, • Clinical Operations Economics & Law. In 1999 he started working within the European Registration department of Sandoz (RCC-EU) and became the From Regulatory Bodies: responsible manager for the administration group. In this function Remco • Chairperson was responsible for planning the submissions of MRP/RUP/DCP’s, variations and renewals; as well as establishing the internal processes and training • Director General e-Regulatory of people. • Regulatory Liaison Since beginning of 2007, Remco changed to the function of Regulatory Affairs Information Manager. In this function he is responsible for tracking all global developments on electronic submissions for Sandoz, as well acting as project manager for Why Now? two SAP databases for the tracking of registrations and variations. Remco is also acting as Chairman of the EGA (European Generics The need for ever evolving knowledge in the area of R&D Association) working group for eCTD. for increased disease, biology and genetic demands means that pharmaceutical companies on average spend 10-20% of their revenues in R&D. In addition, the length Susan Genseberger Susan obtained a MSc in Chemistry from the University of of product market exclusivity, competitive pressure and Amsterdam in 1995. rigorous regulatory procedures requires drug developers She started her career in Regulatory Affairs at Yamanouchi to carefully examine costs to increase the chances of a (nowadays Astellas) where she was responsible for updating & good return on investment. This pressures makes it crucial upgrading the CMC dossiers and the submission & approval of these dossiers for regulatory information to be managed effectively with in European & non-European countries. strategies in place to share information between national She also took care of the distribution regarding regulatory information. affiliates, drug development partners and regulatory In 2002 she changed the European headquarters from Yamanouchi for authorities. Ensuring this process is as simple and seamless a national branch office from Aventis. She became responsible for the regulatory activities of about fifty products (variations, PSURs, SmPC updates, as possible enables quicker submissions and translates into PIL, control of packaging material, review of promotional material) and new significant costs savings. insulin registrations in The Netherlands. When Aventis became Sanofi-Aventis, Susan changed position and became responsible for the review & approval In light of this and with feedback from the market, Pharma of all promotional materials & activities and the training of the employees in IQ’s has launched its inaugural Regulatory Information commercial legislation. Management Conference. This conference is the only event In 2005 Susan moved to Solvay Pharmaceuticals and was appointed a of its kind in the UK to focus solely on the management of liaison function between the chemical and pharmaceutical development department in Weesp and the CMC regulatory affairs departments information within pharmaceutical companies in order to in Germany and the US. Nowadays Susan is responsible for the global aid regulatory submissions. The event will bring together coordination of activities regarding regulatory intelligence, standard leading professionals to focus on the regulatory aspects of operating procedures, training and planning for the regulatory affairs data and information management. department in Abbott (former Solvay). Morwenna Gould is a managing director of Morphiris, a firm specialising in Networking at the Event providing product information management consultancy to the pharmaceutical industry and regulators. Gain unparalleled networking opportunities, with a large She has extensive experience implementing the European Medicines number of senior decision makers through discussion sessions, Agency’s (EMA) PIM standard and has provided consultancy to the EMA, in addition to pharmaceutical companies, to aid them with their extended breaks, case study presentations and critical implementations of PIM. regulatory updates. You will spend crucial face-to-face time with industry experts and position your company as a leading innovator in the oncology development arena. Yann Kervevan Yann is a Pharmacist graduated from the Faculty of Pharmacy in Lyon, France. He started his carrier in Regulatory Affairs where he was in charge of registrations activities (Servier, GSK, Stragen Pharma) and rapidly Speaker Biogs moved to Regulatory Operations position in Sanofi-Pasteur MSD. He joined Extedo GmbH in 2008 where he worked as a Project Manager for Installation, Mickel Hedemand Training and follow-up of various e-tools both in companies and National Mickel Hedemand. M.Sc. in Engineering (production) at Aalborg competent authorities. He is now working for Alexion Pharma International in University in 2004. Certified SAP Consultant (mySAP Supply Lausanne as a Regulator Operations Manager (since June ’10).” Chain Management, Procurement) in 2005 and worked as SAP Consultant for ASA-Mentor/WM data A/S until 2007. Since then he has been Internal Adviser at the Danish Medicines Agency (DKMA), Eldin Rammell Licensing Division comma facilitating and optimising internal processes, Eldin has over 17 years industry experience prior to becoming a consultant. workflow and extracting case and product related data. A key figure in In 2003, Eldin left Pfizer as Associate Director of Records Management and, DKMA’s preparations to receive and archive electronic-only submissions. after a brief journey as a restaurateur, established Rammell Consulting to help Implementation of the common European review system (EURS) at DKMA. companies and organisations improve their records management processes. Technical validation of electronic submissions. He has been a guest lecturer at City University, London and has published articles in the GCP Journal and Clinical Researcher. He is Secretary and past- President of the Good Clinical Practice Records Managers Association (GCP- RMA). +44 (0)20 7368 9300 +44 (0)20 7368 9301 ENQUIRE@IQPC.CO.UK
  6. 6. 5 WAYS TO REGISTER MAIN CONFERENCE: Freephone: 0800 652 2363 or 2nD - 3RD MARCH 2011 +44 (0)20 7368 9300 PRE-CONFERENCE WORKSHOP: 1St MARCH 2011 VENUE: Fax: +44 (0)20 7368 9301 MAyFAIR COnFEREnCE CEntRE, LOnDOn post: your booking form to iQPC, 129 Wilton road, to speed registration, please provide the priority code located on the mailing label or in the box below. ViCtoria, london, my registration code rim slideshare SW1 V1JZ Please contact our database manager on +44(0) 207 368 9300 or quoting the registration code above to inform us of any changes or to remove your details. email: WWW.reginfomanagement.Com register and pay register and pay Standard Packages tick by 24th dec 2010* by 28th Jan 2011* Price team diSCountS* Conference + 2 Workshops + full access save £400 save £300 IQPC recognises the value of learning in teams. Groups of 3 or more booking at the £2996 + Vat to Conference recordings £2596 + Vat £2696 + Vat same time from the same company receive a 10% discount, 5 or more receive a Conference + 1 Workshop** + full save £300 save £200 15% discount, 7 receive a 20% discount. Only one discount available per person. £2497 + Vat access to Conference recordings £2197 + Vat £2297 + Vat Conference + full access to save £200 save £100 £1998 + Vat Venue & aCCommodation Conference recordings £1798 + Vat £1898 + Vat VenUe: Mayfair Conference Centre, 17 Connaught Place, London, W2 2ES Conference + 2 Workshops save £300 save £200 £2497 + Vat aCCommoDation: We look forward to welcoming you to RIM at Mayfair £2197 + Vat £2297 + Vat Conference Centre. To help you get the perfect accommodation and the best special Conference + 1 Workshop** save £200 save £100 £1998 + Vat offers we have put together a unique Mayfair Conference Centre HotelMap that shows £1798 + Vat £1898 + Vat the nearby accommodation options and best possible rates and special offers. Conference only save £100 £1499 + Vat £1499 + Vat The map displays live availability and allows you to book directly with each hotel: £1399 + Vat Alternatively, if you would like Workshop only (half day) £499 + Vat to book your accommodation by phone, you can call Daniel Spinner, our dedicated London concierge, on 020 7292 2335 (if outside UK +44 20 7292 2335) quoting audio recordings £499 + Vat Special Reference Code M64KH. He will be happy to help you with your hotel * to qualify for discounts, payments must be received by the early bird registration deadline. booking and provide assistance organising your time in London. early booking discounts are not valid in conjunction with any other offer. **Please select your choice of Workshop a b uk Vat is charged at 17.5%. Vat registration #: gb 799 2259 67 free online reSourCeS To claim a variety of articles, podcasts and other free resources please visit delegate detailS digital ConferenCe on Cd-rom Please photocopy for each additional delegate A digital version of the conference proceedings, including all presentations, 6 Mr 6 Mrs 6 Miss 6 Ms 6 Dr 6 Other is available to buy. First Name Family Name 6 I cannot attend the event, please send me the CD Rom priced at £599 plus Vat Job Title Tel No. Recent digital conferences available - £599 plus Vat each Email 6 Please send me conference materials indicated above 6 Yes I would like to receive information about products and services via email 6 I have filled out credit card details below Organisation Nature of business For further information Please call: 0207 368 9300 or email: To search IQPC’s archived conference documentation visit: Address Postcode Country Telephone Fax Approving Manager 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 £49 (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 conference. In the event that IQPC cancels an event for any reason, you will receive a credit for Card Number: VISA 6 M/C 6 AMEX 6 100% 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 that 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. 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