3rd Congress Efficient eCTD Submissions 2011
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3rd Congress Efficient eCTD Submissions 2011 3rd Congress Efficient eCTD Submissions 2011 Document Transcript

  • Hea r how key E to U- get Regu tec eCT lato hni Ds rs o cal th n val at age ida rough tio Efficient eCTD nci n es 3rd Congress Submissions 2011 EU- Regulators - New EU Variations Regulation – Lifecycle Management – PIM 31st January – 2nd February 2011 | Meliá Hotel, Berlin Leading companies and institutions will • Meet key EU regulators and gain insights into the adoption and requirements of eCTD to get present case studies and solutions on efficient your submission accepted as quickly as possible eCTd Submissions: • Hear best practices on the successful handling of eCTD lifecycle management and document Bayer Schering Pharma AG, Germany strategies to avoid costly pitfalls Merck Serono, Germany • Profit from first experiences of the New EU Variation Regulation concerning implementation deadlines and consequences Danish Medicines Agency, Denmark • Learn how to adopt eCTD in small and medium-sized companies to make sure that you will College ter Beoordeling van choose the right strategy for your company Geneesmiddelen, CBG-MEB, Netherlands • Hear best solutions on handling Product Information Management (PIM) and gain insights into the Agence Française de Sécurité Sanitaire des impact on eCTD submissions to ensure the best product migration process Produits de Santé, Afssaps, France División Tecnologías Información, Agencia Benefit from contributors such as: Española de Medicamentos y Productos Dr. Adam Aparicio, Head of Global Rob De Haan, Deputy Director MEB, Sanitarios, AEMPS, Spain Regulatory Operations, College ter Beoordeling van Merck Serono, Germany Geneesmiddelen, Netherlands Gebro Pharma GmbH, Austria PARI Pharma GmbH, Germany Elke Schydlo, Technical Services, Global Miguel BLEy, Head of European Affairs, Regulatory Affairs Agence Française de Sécurité Sanitaire German Medicines Manufacturers Manager, Submission Services Hannover, des Produits de Santé (Afssaps), France Association, BAH, Germany Abbott Products GmbH, Germany Federal Institut for Drugs and Medical Devices, BfArM, Germany INTERACTIVE WORkSHOP DAy | Wednesday, 2nd February 2011 Abbott Products GmbH, Germany A Implementation of eCTD in sme (small and medium-sized companies) B eCTD Technical Validation Criteria - How to get eCTDs through technical validation Schering Plough Netherlands B.V., at agencies Netherlands C Successfully managing eCTD Lifecycles 10 y 20 b ! Astellas Pharma Europe R&D, Netherlands r ok D PIM & eCTD VE be bo em ou ov y SA Sponsor Medienpartner Supported by Researched and developed by N - if 0, th 9 12 € 2 th p to u eTo Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.ectd-kongress.de/MM
  • Efficient eCTD Submissions 2011 3rd Congress 31st January – 2nd February 2011 | Meliá Hotel, Berlin Dear colleagues, Who will you meet? Submission documents have traditionally been handed in to agencies on paper, meanwhile electronic systems • Regulatory Affairs • Global Regulatory Operations are used for building and managing these documents. Nowadays electronic-only submission (eCTD) is, how- • Documentation Management ever, becoming ever more mandatory. For example, since 2009 electronic-only submission has been mandato- • Submission Management ry at the EMA in England. eCTD could constitute a huge advantage for pharma industries because the submis- • Regulatory Lifecycle Management sion time can be substantially reduced, allowing for a quicker release of products onto the market. However, • IT Regulatory Support the implementation and handling of eCTD are problematic due to different standards at each European agency. The implementation of eCTD in the company also means a change of the workflow and a high demand on archiving and managing the electronic documents (lifecycle management). Furthermore the Sponsorship New EU Variations Regulation (since January 2010) denotes modification when it comes to reporting varia- tions to the agency. We have a variety of packages available to suit your requirements. For all Sponsorship and Exhibition Discuss the challenges of efficient eCTD submissions at our opportunities call Ralph Grundmann: +49 (0) 30 20 91 32 75 or email ralph.grundmann@iqpc.de. 3rd Congress Efficient eCTD Submissions EU Regulators – New EU Variations Regulation – Lifecycle Management – PIM Sponsor 31.01.-02.02.2011 | Meliá Hotel, Berlin Find out how to: • get eCTDs through technical validation at agencies COI GmbH • prepare PIM submissions Erlanger Strasse 62 91074 Herzogenaurach, Germany • implement eCTD in small and medium-sized companies Tel.: +49 (0)9132 7383 3417 Fax: +49 (0)9132 7383 4959 Join our expert panel, save your place and book today! Email: andrej.sosnin@coi.de www.coi.de We look forward to welcoming you to our 3rd congress Efficient eCTD Submissions in Berlin! Kind Regards, For further information please visit our website www.ectd-kongress.de/MM or con- Team Discounts tact Hannah Schädler or Monica Wick Mark Reichmann via We are offering attractive Team Project Manager email eq@iqpc.de. Discounts, please contact us! Medienpartner Obtaining drug marketing authorisation in the EU is a complex process, necessitating a broad range of knowledge in various areas of specialisation that requires Regulatory Affairs Managers to be a pharmacist, lawyer, quality manager and project manager in one. You can use various sources to draw up marketing authorisation applications, but if you are not sure what exactly you are looking for, it is easy to get lost in the sheer abundance of information and lose valuable time. In contrast, the Guide to Drug Regulatory Affairs eases you through the necessary procedures, comments on EU and EMEA documents and helps you draw up your application. ECV • Editio Cantor Verlag GmbH www.ecv.de Since 72 years, pharmind® has been the periodical to be read by decision-makers and multipliers of the pharma scene. Taking into consideration the national and international (in particular EU and FDA) regulatory environment, the entire range of issues involving the development, manufacture, and marketing/sales of pharmaceutical products is covered in depth. www.ecv.de www.PharmCast.com is the world leading website designed specifically for pharmaceutical, clinical and biotechnology profes- sionals. www.PharmCast.com brings up-to-date information on pharmaceutical patents, FDA, news, jobs and Buyers Guide to our visitors. It was created and is maintained by pharmaceutical and biotechnology professionals. Visit www.PharmCast.com and discover for yourself why it is so popular among professionals. www.pharmcast.com wPharmaVOICE magazine addresses the challenges and trends impacting the life-sciences industry. PharmaVOICEs subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers. www.pharmavoice.comTo Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.ectd-kongress.de/MM
  • Efficient eCTD Submissions 2011 3rd Congress CONGRESS DAy ONE | Monday, 31st January 2011 09:30 Registration with coffee and tea PIM & eCTD/ digital signatures 09:55 Chairman’s welcome & opening address 15:00 The PIM Project - Exchange of well structured product New EU Variations Regulation information • Why Product Information Management (PIM)? 10:00 Regulators view: Consequences of the New Variation • Structure and elements of the PIM-Project Regulation for the eCTD • Impact on the procedures of regulators and industry • EU Module 1.4 specification • Status Update and next steps • Switch from 1.3 to 1.4 during life-cycle Dr. Andreas Franken, Abteilungsleiter Klinische Forschung/ • Worksharing and grouping, annual reporting elektronische Datenübermittlung, Dr. Klaus Menges, Division Strategy and Planning-Unit BAH Scientific Quality Assurance and Process Organisation, Federal Institut for Drugs and Medical Devices, BfArM 15:45 PIM Submissions • Exchanging data in PIM 10:45 Industry View: 1 year New Variations Regulation • The PIM process / communication within PIM • Experiences from MRP and DCP • The lifecycle of PIM / DES • Q&A Document for eCTD Variations - open questions • PIM implemetation in eCTD • Impact of "Grouping" and "Annual reporting" on internal Markus Pfahlert, Global Regulatory Operations, business processes" Merck Serono Dr. Hannes Perschinka, Regulatory Support, Gebro Pharma GmbH 16:30 Refreshment break & networking 11:30 Refreshment break & networking 17:00 Digital signatures in eSubmissions in Europe • Why digital signatures? The use of electronic submission eCTD in a special environment gateways • The SAFE standard 12:00 Case Study: Managing MAH and Manufacturer Name • The use of ‘flattened’ digital signatures Change Submissions in the case of a Company Take-Over • Pilot of digital signatures • Name Change Project Introduction • Acceptance of digital signatures in the EU • Tools used for Submission Planning and Tracking Hans van Leeuwen, Program Manager, • From high level planning to approval offirst submissions Schering Plough Netherlands B.V. • Reporting tools • Logistic of Submissions in Europe 17:45 Closing remarks of the chairman and end of day one • Submission Formats used • Impact of New Variations Guideline Elke Schydlo, Technical Services, Global Regulatory Affairs Manager, Submission Services Hannover, Abbott Products GmbH The Meliá Berlin invites you to an evening reception. This is an excellent opportunity 12:45 Challenges faced by small and medium-sized companies for you to meet the other attendees and • Does it make sense to implement eCTD in my company? make new business contacts. • How do I get started? • Two case studies • Dos and Donts Oliver Denk, PhD, Director, Regulatory Affairs Pharma, PARI Pharma GmbH For further Information 13:30 Networking Luncheon please visit our website www.ectd-kongress.de/MM or contact Hannah Schädler or Mark Reichmann on +49 (0)30 2091 32 74 or email eq@iqpc.de. What’s in your download center? The purpose of the download center is to provide you with relevant content to enhance your knowledge of current trends and industry news. All content is 100% complimentary, easy to download, and current. Featuring live podcast interviews, available to stream on your computer or portable device, up-to-date news from local and international sources, industry whitepapers, and other relevant content – the download centre is your online portal for expanding your knowl- edge and adding value to your business. We encourage your feedback and participation. For all comments or enquiries please contact Mark Reichmann or Hannah Schädler on +49 (0)30 20 91 32 74 or eq@iqpc.de. Get free white papers, articles and much more! www.ectd-kongress.de/MMTo Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.ectd-kongress.de/MM
  • Efficient eCTD Submissions 2011 3rd Congress CONGRESS DAy TWO | Tuesday, 1st February 2011 08:30 Registration with coffee and tea 13:20 Practical experience in handling eCTD submissions in Spanish Medicine Agency 08:55 Chairman’s welcome & opening address • eCTD and NeeS submission: Pros and Cons Dr. Adam Aparicio, Head of Global Regulatory Operations, Regulator • Impact of the eCTD on regulatory processes Merck Serono, Germany • Common problems handling eCTDs in Spanish Medicine Implementation and requirements of eCTD by EU Agency Regulators José Manuel Simarro, División Tecnologías Información, Agencia Española de Medicamentos y Productos 09:00 Electronic Marketing Authorisation Applications in Sanitarios, AEMPS Europe Today • e-Readiness : Regulators and Industry Lifecycle Management – document strategies Regulator • EU Harmonisation: Guidance and Validation of submissions • The French experience 14:00 One year of eCTDs in Switzerland - a project review Miguel Bley, Head of European Affairs, • How to build Swiss Module 1 in eCTD Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps) • Ensuring successful validation of your submission • Article 13 in eCTD - referring to existing approvals abroad 09:40 e-submissions at the MEB and the EU portal • Dos and donts for Swiss eCTDs • Current status of e-submissions at the MEB Jörg Schnitzler, Associate Director Regulatory Operations, • Validation: Improving quality of your submission Regulatory Affairs Europe, Regulator • CESP: The EU portal dream or reality Astellas Pharma Europe R&D Rob De Haan, Deputy Director MEB, College ter Beoordeling van Geneesmiddelen, 14:45 Refreshment break & networking Netherlands 10:20 Refreshment break & networking 15:15 eCTD Lifecyle management: Milestones and Hurdles in a DCP 10:50 Experiences with e-only eSubmissions in Germany • Initial Submission and Approval • Conditions to move to e-only • Lifecycle of the application (Variations, PSURs, FUMs, etc) • Technical validation: improvement or burden • eCTD and Worksharing Regulator • Quality of the dossiers • Feedback from Authorities • Recommendations for the future Dr. Christian Dinter, Global Submission Manager, Dr. Klaus Menges, Division Strategy and Planning-Unit Scientific Quality Assurance and Process Organisation, Bayer Schering Pharma AG, Germany Federal Institut for Drugs and Medical Devices, BfArM 16:00 Strategies for documents and lifecycle management 11:30 Experience with e-only submissions in Denmark • Document preparation • Requirements for applicants • Granularity options - high vs. low • Experience from validation of e-submissions • Hyperlinking strategy options Regulator • Quality of dossiers received • Publishing and dossier lifecycle / re-usage • Working in the Danish Agency’s fully digitalised environment Dr. Adam Aparicio, Head of Global Regulatory Operations, Per Helboe, Senior Director of Division, Danish Medicines Agency Merck Serono, Germany 12:10 Networking Luncheon 16:45 Closing remarks of the chairman and end of congress day two Register for our email updates! Get the latest news on our events, additional download possibilities, early bird deadlines and much more! Register now at www.ectd-kongress.de/MM. IQPC provides business executives around the world with tailored practical congresses, large scale events, topical seminars and in-house training programs, keeping them up-to-date with industry trends, technological developments and the regulatory landscape. IQPC’s large scale congresses are market leading “must attend” events for their respective industries. IQPC produces more than 1,500 events annually around the world, and continues to grow. Founded in 1973, IQPC now has offices in major cities across 5 continents including: Berlin, Dubai, London, New York, São Paulo, Singapore, Stockholm, Sydney and Toronto. IQPC leverages a global research base of best practices to produce an unrivalled portfolio of congresses. www.iqpc.deTo Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.ectd-kongress.de/MM
  • Efficient eCTD Submissions 2011 3rd Congress INTERACTIVE WORkSHOPDAy | Wednesday, 2nd February 2011 Workshop A Implementation of eCTD in sme (small and medium-sized companies) 09:30 – 13:00 As eCTD submissions are becoming the norm rather than an exception small and medium-sized companies are now trying to match their capabilities to what are now industries requirements. The implementation of eCTD format will require a huge effort therefore it is important to identify priorities in this process. The participants of the workshop will learn: • How to reach a decision whether to choose an in-house solution or an outsourcing solution. • What criteria need to be looked at when choosing the right software tool for eCTD publishing? • What is the best approach to implement eCTD in your company? • Which departments need to be involved in the process? The workshop will be held in a very interactive manner. Oliver Denk, PhD, Director, Regulatory Affairs Pharma, PARI Pharma GmbH Workshop B eCTD Technical Validation Criteria - How to get eCTDs through technical validation at agencies 09:30 – 13:00 The EU eCTD Validation Criteria (v2.1) were published in April 2009. Many European agencies have already started to perform technical validation of incoming eCTDs and to reject eCTDs not complying with the validation criteria. Different tools for checking the validation criteria are made available to the public by agencies and vendors (EURS Validator, eValidator, eCTD Checker). As the interpretation of validation criteria is different between the tools, one eCTD may lead to different validation results than another. This workshop will cover • Introduction to publicly available validation tools (EURS Validator, eValidator, eCTD Checker) • Interpretation of validation results from different tools • How should an eCTD be structured to pass all (publicly available) validation tools? • Outlook on update of EU eCTD Validation Criteria: TIGes has announced that it will issue updated EU validation criteria by the end of 2010 Dr. Hannes Perschinka, Regulatory Support, Gebro Pharma GmbH Workshop C Successfully managing eCTD lifecycles 14:00 – 17:30 To handle the eCTD lifecycle successfully means to be aware of some common pitfalls. Therefore this workshop will provide you with solutions to solving problems which arise during lifecycle management. The following topics will be covered: • Defining level of granularity • Hypertext link/bookmarking • Changes during lifecycle • Grouping and worksharing • Switch from paper to eCTD during lifecycle For further Information visit our website: www.ectd-kongress.de/MM Workshop D PIM & eCTD 14:00 – 17:30 The content of product information texts for medicinal products is part of any marketing authorisation. SPC, package leaflets and labeling contain important information for both patients and for professionals such as doctors and pharmacists. The marketing authorisation holder is responsible for the creation as well as for the maintenance of these informative texts. While for a national approval only a few pages of text are necessary, the scope of work expands as soon as the product is marketed in multiple countries with different languages and in addition in different strengths and / or formulations. A structured electronic generation and submission of these texts, starting with the centralized procedure and maybe later also for other drug application procedures, is needed as even today the basic regulatory processes are increasingly converted to paperless communication. The workshop will vividly demonstrate the preparation and handling of product information in accordance with the requirements of the EMA for PIM. For this the structure of XML documents with the basic idea of multiple use of information and their advantages in the document maintenance are presented and explained. This includes an introduction to the free tool for this purpose, the EMA (Light Authoring Tool, LAT). Dr. Andreas Franken, Clinical Research / eSubmission, German Medicines Manufacturers Association, BAHTo Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E info@iqpc.de | www.ectd-kongress.de/MM
  • 4 Ways to Register Fax: +49 (0)30 20 91 33 12 Post: IQPC Gesellschaft für Management Konferenzen mbH 31st January – 2nd February 2011 | Meliá Hotel, Berlin Friedrichstraße 94 10117 Berlin, Germany Online: www.ectd-kongress.de/MM If undeliverable, please return to: IQPC GmbH | Friedrichstraße 94 | D-10117 Berlin, Germany Email: info@iqpc.de For further information Phone: +49 (0)30 20 91 33 30 BOOKINGCODE PDFW Venue and Accommodation Meliá Berlin Friedrichstraße 103 10117 Berlin, Germany Tel.: +49 (0)30 206079 00 Fax: +49 (0)30 206079 0444 Email: melia.berlin@solmelia.com www.meliaberlin.com yOUR DETAILS: PLEASE CONTACT OUR DATABASE MANAGER (VERTEILER@IQPC.DE) AND INFORM THEM OF ANY INCORRECT DETAILS WHICH WILL BE AMENDED ACCORDINGLY Welcome to the Meliá Berlin. Centrally Early Bird Congress Packages Standard Price positioned at Friedrichstrasse, which (Book and pay by the 12th November 2010) Platinum Package runs along the banks of the river Spree, Save € 290,- € 2.609,- +VAT € 2.899,- + VAT 2 day congress plus 2 workshops the hotel is within walking distance of many famous sights. Gold Package Save € 260,- € 2.339,- +VAT € 2.599,- + VAT Spanish passion and attention to detail are the trademark of the 2 day congress plus 1 workshop Meliá brand. Welcoming colours combine with a spacious work Bronze Package € 2.199,- + VAT 2 day congress desk and Wi-Fi Internet access to fulfil the all needs in each of Workshop Day € 1.399,- + VAT our 364 guest rooms and suites. For the most discerning execu- tives, we offer “THE LEVEL rooms featuring upgraded amenities ” Please indicate choice of workshop on 2nd February 2011 and access to our Executive Club “THE LEVEL on the 7th floor. ” Workshop A I Workshop B I Workshop C I Workshop D Enjoy the look out to “Friedrichstraße” as you share cocktails and light appetizers at the Bar “meliá tapas” Savour a unique fusion of . A: Implementation of eCTD in sme (small and medium-sized companies) Spanish and German cuisine at the restaurant “Café Madrid” The . B: eCTD Technical Validation Criteria - How to get eCTDs through technical validation at agencies Meliá Berlin offers 1.200 square meters of sophisticated function C: Successfully managing eCTD lifecycles D: PIM & eCTD space. Only one discount applicable per person. Accommodation: A limited number of reduced rate rooms are CANT MAKE IT TO THE CONGRESS? PURCHASE THE 2-DAy CONGRESS DOCUMENTATION FOR € 595,- +VAT. available at the conference hotel. Accommodation can Delegate Details be booked by calling the central reservation number. Please fill out in Capitals! Please always quote the booking reference IQPC-Berlin. Hotel DELEGATE Mr Mrs Ms Dr accommodation and travel costs are not included Family Name First Name in the registration fee. Position Email Payment Terms Telephone Fax Payment is due within 2 weeks after receipt of the invoice. Organisation Address Cancellations and Substitutions CANCELLATIONS AND SUBSTITUTIONS DELEGATES MAY BE SUBSTITUTED AT ANY TIME. IQPC GESELLSCHAFT FüR Postcode/Town MANAGEMENT KONFERENzEN MBH DOES NOT PROVIDE REFUNDS FOR CANCELLATIONS. HOWEVER, SAVE WHERE WRITTEN NOTICE OF CANCELLATION Approving Manager: IS RECEIVED MORE THAN SEVEN (7) DAYS PRIOR TO THE CONGRESS, A CREDIT TO THE VALUE PAID AT THAT DATE WILL BE ISSUED, WHICH MAY BE USED Signature AGAINST ANOTHER IQPC GMBH CONGRESS FOR UP TO ONE YEAR FROM ITS DATE OF ISSUE. 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