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 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
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To 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 Buyer's 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. PharmaVOICE's subscribers
                                     are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and
                                     White Papers. www.pharmavoice.com


To 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 Don'ts
              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/MM



To 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 don'ts 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




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To 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, BAH



To 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
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                              31st January – 2nd February 2011 | Meliá Hotel, Berlin
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                                                                                                                                                              Online:     www.ectd-kongress.de/MM
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                              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.

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3rd Congress Efficient eCTD Submissions 2011

  • 1. 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 e To 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
  • 2. 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 Buyer's 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. PharmaVOICE's subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers. www.pharmavoice.com To 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
  • 3. 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 Don'ts 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/MM To 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. 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 don'ts 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.de To 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
  • 5. 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, BAH To 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
  • 6. 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 CAN'T MAKE IT TO THE CONGRESS? PURCHASE THE 2-DAy CONGRESS DOCUMENTATION FOR € 595,- +VAT. available at the conference hotel. 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