12th Conference on European Electronic Document Management

12th Conference on European Electronic Document Management New Practices beyond Document Management Event #11104 30 November - 2 December 2011 Swissotel, Zurich, Programme Co-Chairs Dimitri Stamatiadis, Director Management Processes, Merck Serono, Hans van Bruggen, Senior Regulatory Affairs Consultant, ectdconsultancy, Programme Committee Thomas Altenwerth, Head of Global Regulatory Affairs Archives Wuppertal, Bayer HealthCare Pharmaceuticals, Overview For the past few decades, as we moved from paper-based content to electronic files, we have kept a clear distinction between documents and data, and the context in which this content was used. Data was managed in structured databases, analysed, then transferred manually, and documents were recreated over and over again and stored in Electronic Document Management (edm) systems. Today this separation is slowly disappearing as new technologies, such as Extensible Mark-up Language (XML), bring documents, data and other forms of information together in one melting pot. This evolution is welcome and opens new perspectives in areas such as collaboration, reuse, review, analysis and records management. It also creates new challenges and pharmaceutical professionals will need to revise their view and practices and gradually move from traditional data and document management to information and content management. DIA has always been in the forefront of new ideas and technologies and will once more offer a privileged forum for discussing, understanding and addressing the new challenges of information management. Melanie J. Clare, Global Head, Clinical Document Management & Publishing, GlaxoSmithKline, Joris Kampmeijer, Head of Information Processing, Medicines Evaluation Board, Anita Paul, Head of Corporate Records Management, F. Hoffmann-La Roche AG, Continuing Education The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this conference with 12 credits. Who Will Attend Academic researchers Agency representatives (e.g. inspectors and reviewers) Clinical operations representatives CMC regulatory compliance specialists CROs, CMOs and service providers Document and records managers IT and support personnel Knowledge/IP professionals Labelling specialists Medical and technical writers Pharmacovigilance professionals Quality assurance and compliance professionals Regulatory affairs/operations representatives Standards implementation specialists and associates Validation professionals Pre-Conference Tutorials Wednesday, 30 November 2011 09:00-17:00 Tutorial 1: ELECTRONIC TRIAL MASTER FILE (etmf) - MIGRATING FROM PAPER TRIAL MASTER FILES TO ELECTRONIC Exhibition Opportunities Available! Last year s edm conference attracted delegates from 20 countries. Showcase your product or service to a truly global audience of qualified professionals, from entry level to expert, in the pharmaceutical, biotechnology, devices and related healthcare industries, government, academia and healthcare delivery. For more information on exhibiting space and facilities, please contact Natacha Scholl at DIA Europe on +41 61 225 51 59 or email: natacha.scholl@diaeurope.org Tutorial 3: Document Management, earchiving, Records Management: From good to great - A practicum beyond document management

2 Pre-Conference Full Day Tutorials on Wednesday, 30 November 2011 08:30 Arrival & Registration Tutorial 1 09:00 17:00 etmf - MIGRATING FROM PAPER TRIAL MASTER FILES TO ELECTRONIC Tutorial Co-Instructors: Eldin Rammell, Managing Director, Rammell Consulting Limited, Karen Redding, Business Development Director, Phlexglobal Ltd, This tutorial will provide a comprehensive overview of the issues involved in implementing an electronic trial master file. In addition to covering foundation principles such as what is the trial master file, this interactive session will provide guidance in a wide range of related aspects, including: what do the regulations say about etmfs how should documents be filed in an etmf metadata and naming conventions what formats are acceptable how can the etmf be reviewed by end-users, auditors and inspectors how can an etmf support global clinical trials how is the etmf populated and maintained what are the validation requirements does an etmf need electronic signatures LEARNING OBJECTIVES 1. Understand the regulatory requirements for etmfs 2. Recognise the impact of an etmf on trial-related processes 3. Understand different approaches to etmf design 4. Participate actively in project planning and implementation 5. Develop useful user requirements for an etmf 6. Evaluate potential IT solutions Tutorial 3 09:00 17:00 Document Management, earchiving, Records Management: From good to great - A practicum beyond document management Tutorial Co-Instructors: Thomas Altenwerth, Head of Global Regulatory Affairs Archives Wuppertal, Bayer HealthCare Pharmaceuticals, Russell Joyce, Director & Principal Consultant, Heath Barrowcliff Consulting Ltd, This tutorial will provide an important foundation for conference participants towards a holistic view on documentation practice. Documentation is a key asset to develop and market pharmaceutical products. Whilst focussing on document preparation, the value of your documents post finalisation should not be neglected. Ideally this can be addressed by building in Records Management practices right from the beginning. This tutorial will help leverage a full and efficient control over your documentation by covering: key aspects of Document and Records Management, their overlap and difference paper vs. electronic implementation of records management processes meta data and retrieval electronic Archiving: challenges of long-term retention requirements for technology and systems non-submission documents and other data sources practical examples Key Learning Objectives know the difference between Document, Records Management and Archiving know why all three are important and when know the framework with its relevant regulations and industry standards know what can you expect from Systems and Tools know the relevant questions towards the best approach for your organisation 10:30-11:00 Coffee Break 12:30-14:00 Lunch Break 15:30-16:00 Coffee Break THURSDAY 1 DECEMBER 2011 START OF CONFERENCE 08:00 REGISTRATION AND WELCOME COFFEE 09:00 SESSION 1 WELCOME AND INTRODUCTION Dimitri Stamatiadis, Project Director, Merck Serono, Hans van Bruggen, Senior Regulatory Affairs Consultant, ectdconsultancy, For the past few decades, as we moved from paper-based content to electronic files, we have kept a clear distinction between documents and data, and the context in which this content was used. Data was managed in structured databases, analysed, then transferred manually, and documents were recreated over and over again and stored in edm systems. Today this separation is slowly disappearing as new technologies, such as XML, bring documents, data and other forms of information together in one melting pot. This evolution is welcome and opens new perspectives in areas such as collaboration, reuse, review, analysis and records management. It also creates new challenges and pharmaceutical professionals will need to revise their view and practices and gradually move from traditional data and document management to information and content management. Keynote Speakers: To Have and to Hold Records/data management and ediscovery in the financial industry Britta Delmas, Global Head of ediscovery, UBS AG, esubmissions in Crop science Felix Meier-Manz, Lead CP Regulatory Knowledge, Management and Support, Syngenta Crop Protection AG, 10:30 COFFEE BREAK IN THE EXHIBITION AREA

3 THURSDAY 1 DECEMBER, 2011 PARALLEL SESSIONS 11:00 SESSION 2 SUBMISSIONS IN A GLOBAL ENVIRONMENT Joris Kampmeijer, Head of Information Processing, Medicines Evaluation Board, The first ectd experiences were focused towards a single product for a single region/country. Now ectds have become daily business many companies, it has to fit in daily business. Companies have to create and maintain dossiers for all their products registered in a wide variety of countries, resulting in country-specific dossier. Even if it concerns countryspecific dossiers, the majority of documents could be reused. However, most companies are struggling with handling a single source of documents and creating a variety of country-specific dossiers in different formats managed by various groups of people around the world. Experience and lessons learned at pharma-companies will be shared. Global esubmissions by a Centralised organisation Carolline Petersen, Senior Project Coordinator, Publishing Support, Regulatory Operations, Novo Nordisk A/S, Denmark How can baseline dossiers support global esubmissions? Hans van Bruggen, Senior Regulatory Affairs Consultant, ectdconsultancy, 11:00 PARALLEL SESSION 2 CONSIDERATIONS FOR SETTING UP AN etmf Thomas Altenwerth, Head of Global Regulatory Affairs Archives Wuppertal, Bayer HealthCare Pharmaceuticals, This session will identify the main challenges in transitioning from a paper to an electronic TMF. We will provide a comprehensive view from archiving at the Investigator s site to the recent efforts for TMF standardisation across the industry. Constructing an etmf The do s and don ts of edm Christoph Langebner, Senior Account Executive, CSC Life Sciences, Denmark TMF Reference Model Leveraging for success Karen Redding, Business Development Director, Phlexglobal Ltd, Experience with etmfs and Investigative Site Archiving Michael Smyth, General Manager Life Sciences Solutions, TransPerfect, Lessons learnt with global submissions Joerg Schnitzler, Associate Director Regulatory Operations, Regulatory Affairs Europe, Astellas Pharma Europe R&D 12:30 LUNCH IN THE EXHIBITION AREA 14:00 SESSION 3 AGENCY UPDATE Hans van Bruggen, Senior Regulatory Affairs Consultant, ectdconsultancy, Gary Gensinger, Deputy Director, Office of Business Informatics, Center for Drug Evaluation and Research, FDA, Joris Kampmeijer, Head of Information Processing, Medicines Evaluation Board, Rob de Haan, MEB Representative at Telematics Implementation Group for electronic submission (TIGes) and EU Representative at ICH M2 Urs A. Niggli, Head, Support Marketing Authorisations, Swissmedic, 14:00 PARALLEL SESSION 3 etmf SPECIAL INTEREST TOPICS Eldin Rammell, Managing Director, Rammell Consulting Limited, The implementation of etmf technology is more than simply purchasing electronic document management software. Successful implementation requires overcoming a number of organisational, process and compliance hurdles. This session will provide the answers to some of the key issues we face. Integration of emails into the Trial Master File Russell Joyce, Director & Principal Consultant, Heath Barrowcliff Consulting Ltd, Destruction of Paper Is it Possible? Position of the DIA DRM SIAC Working Group Co-presenters: Lisa Mulcahy, TMF Document Management Consultant, Mulcahy Consulting LLC, & Steve Scribner, Managing Consultant, International Life Science Solutions, Presentation etmf Inspector s perspective Andrew Fisher, Senior GCP Inspector, MHRA, 15:30 COFFEE BREAK IN THE EXHIBITION AREA 16:00 SESSION 4 REGULATORY OPERATIONS ROUNDTABLE Melanie J. Clare, Global Head, Clinical Document Management & Publishing, GlaxoSmithKline, Panellists: Gary Gensinger, Deputy Director, Office of Business Informatics, Center for Drug Evaluation and Research, FDA, Joris Kampmeijer, Head of Information Processing, Medicines Evaluation Board, Rob de Haan, Deputy Director, The Telematics Implementation Group for electronic submission and ICH Implementation (TIGes), EMA, EU Urs A. Niggli, Head Support Marketing Authorisations, Swissmedic, 16:00 PARALLEL SESSION 4 TMF ROUND TABLE Anita Paul, Head of Corporate Records Management, F. Hoffmann-La Roche AG, Panellists: Russell Joyce, Director & Principal Consultant, Heath Barrowcliff Consulting Ltd, Lisa D. Mulcahy, TMF Document Management Consultant, Mulcahy Consulting, LLC, Andrew Fisher, Senior GCP Inspector, MHRA, Karen Redding, Business Development Director, Phlexglobal Ltd., Eldin Rammell, Managing Director, Rammell Consulting Limited, 17:30 DRINKS RECEPTION IN THE EXHIBITION AREA 18:30 GUIDED TOUR THROUGH ZURICH 19:30 END OF DAY ONE

4 FRIDAY 2 DECEMBER 2011 08:00 WELCOME COFFEE IN THE EXHIBITION AREA 08:30 SESSION 5 edm NOW AND BEYOND Dimitri Stamatiadis, Project Director, Merck Serono, edm has been around for a long time in pharmaceuticals and edm systems have become an integral part of the infrastructure in all big companies. Nevertheless, new challenges emerge daily: smaller companies need to address documentation management in a cost-efficient way, federation of R&D resources is forced upon the industry by the markets and collaboration at all levels is made possible thanks to new technical possibilities. Where are we going from here? A snapshot view of the state of the edm is a must at this time. 2011 Industry Benchmark in Enterprise Content Management and Collaboration Strategy Steve Scribner, Managing Consultant, International Life Science Solutions, Small Company Perspective The cloud is the answer, the sky is the limit Kate Wilber, Senior Product Manager, Veeva Systems Inc., Collaboration Beyond the Firewall Sanne Godiksen, Project Manager & Senior Business Consultant, Life Science Division, NNIT A/S, Denmark 10:00 COFFEE BREAK IN THE EXHIBITION AREA 10:30 SESSION 6 REGISTRATION TRACKING Thomas Altenwerth, Head of Global Regulatory Affairs Archives Wuppertal, Bayer HealthCare Pharmaceuticals, At the edm conference, we are focusing on best practice electronic document and submission management. With the increasing standardisation and integration of processes in the pharmaceutical industry, seeing the big picture gets more and more important. This session on registration tracking provides a look beyond our familiar edm process chain. 10:30 PARALLEL SESSION 6 CLINICAL RESEARCH ORGANISATIONS (CROs) AND SMALL & MEDIUM SIZE ENTERPRISES (SMEs) Hans van Bruggen, Senior Regulatory Affairs Consultant, ectdconsultancy, Over the past decades, pharma companies have invested heavily in systems and processes to meet regulatory requirements. With more focus on resource efficiency, these companies are now looking at alternative ways of achieving results a path that SMEs had to pioneer from the beginning. GSM 2.0: Implementation Considerations Amanda Keller, Senior Process Consultant Europe, Octagon Research Solutions Ltd., Leveraging Cloud-Based Solutions for the Exchange of Critical Documents in Clinical Trial Management Jason Hemingway, Marketing Manager EMEA, Intralinks Ltd., Industry Submission Registration Information for Compliance Cynthia F. Piccirillo, Director, Global Dossier Management estrategy, Bristol-Myers Squibb Company, Small Enterprise CRO Perspective on eclinical Documentation Rolf Marugg, Head Drug Regulatory Affairs, Appletree AG, Preparing and Tracking Submissions and Approvals Globally Nancy Vermeiren, Director Global Regulatory Affairs GRA-CMC, Janssen Pharmaceutica NV, Belgium Implementing a corporate DMS in a mid size company: The transition to information management Esther O Driscoll, Group Leader EDMS, Actelion Pharmaceuticals Ltd., 12:00 LUNCH IN THE EXHIBITION AREA Exhibiting Companies Company Country NextDocs CSC DoubleBridge Technologies, Inc. Exalon GmbH EXTEDO fme AG Liquent LORENZ Life Sciences Group Montrium Canada Company NNIT A/S Octagon Research Solutions Ltd Phlexglobal Limited Product Life AG QUMAS TransPerfect Veeva Systems Wingsplan Technology, Inc. Zinc Ahead Ltd Country Denmark Ireland Exhibition opening hours Thursday, 1 December 2011 From 10:00 18:30 Networking reception: from 17:30-18:30 in the exhibition hall Friday, 2 December 2011 From 10:00 15:30

5 FRIDAY 2 DECEMBER 2011 13:30 SESSION 7 IRISS Joris Kampmeijer, Head of Information Processing, Medicines Evaluation Board, 13:30 PARALLEL SESSION 7 MERGERS & ACQUISITIONS Melanie J. Clare, Global Head, Clinical Document Management & Publishing, GlaxoSmithKline, On-Going Progress of the IRISS Forums Andrew P. Marr, Managing Director, Marr Consultancy Limited, ETICS III The IRISS ectd Tools Interoperability and Compliance Study Harv W. Martens, President, ING America, Inc., IRISS Lifecycle Topic Group Options for the presentation of ectd messages Alastair Nixon, Director, Submission Publishing, GlaxoSmithKline, The Intersection of Metadata and Documents A case study on integration of records management practices after a merger Jimmy Chen, Vice President, DoubleBridge Technologies Inc., Buy 3 - Get 1: Migration of 3 submission management systems into 1 Adam Aparicio, Partner, IFEMA - Institue for Effective Management, Good Management Practice (GMP) Controlled Documents Throughout a Merger Wolfgang Schumacher, Head of Pharma Technical Quality Computer Systems, Roche, 15:00 COFFEE BREAK IN THE EXHIBITION AREA 15:30 SESSION 8 DITA AND esignature Dimitri Stamatiadis, Project Director, Merck Serono, This session will address to other aspects associated to electronic document/data management, namely compound authoring and electronic signatures. After the closure of the PIM project, alternatives have to be explored to address the same business need. DITA OASIS Standard (www.dita.xml.org), an XML architecture for designing, writing, managing, and publishing information might offer a solution. The other topic will address the benefits and constraints of electronic signatures as alternative for internal paper based approval procedures and wet signatures on paper documents. esignatures throughout the Lifecycle Jonathan Burd, Solution Director, GxPi, Structured Product Information with DITA A well established XML standard since 2004 Christian Kravogel, Product Manager, EXTEDO GmbH, CLOSING OF CONFERENCE Dimitri Stamatiadis, Project Director, Merck Serono, 16:30 END OF CONFERENCE Hotel Information DIA Europe has blocked a limited number of rooms at the: Swissotel Zürich Am Marktplatz Oerlikon Schulstrasse 44 CH-8050 Zürich Tel: +41 44 317 31 11 Fax: +41 44 317 33 59 www.zurich.swissotel.com at the special rate of CHF 225.00 single occupancy including service and VAT but excluding CHF 2.50 city tax. Full American breakfast is at CHF 35.00 per person. To reserve a room, click on the link: https://reservations.swissotel.com/availability.aspx?property=szu&promo=pdia&lang=en IMPORTANT: To be assured of accommodation at Swissotel Zürich, registrants are recommended to complete their reservation by 14 November 2011 latest.

REGISTRATION FORM 12th Conference on European Electronic Document Management 30 November - 2 December 2011 Swissotel, Zurich, ID # 11104 If DIA Europe cannot verify your membership upon receipt of the registration form, you will be charged the non-member fee. The fee is inclusive of lunch and coffee breaks of EUR 125.00 per day. Early-Bird rates available for Members: Deadline on or before 18 October 2011 Join DIA now to qualify for the early-bird member fee! To qualify for the early-bird discount, registration form and accompanying payment must be received by the date above. Does not apply to government/academia/non-profit members Early-Bird Industry Fee for members (on or before 18 October 2011)* 1 165.00 Join DIA now to qualify for the member rate 115.00 CATEgory Member (after 18 october 2011) Fee* Non-Member Fee* Industry 1 365.00 1 480.00 government/charitable/non-profit/academia (Full-Time) 683.00 798.00 * All fees will be subject to the local Swiss vat at 8% Tutorial Wednesday, 30 November 2011 Fee* Tutorial Fee 550.00 guided Tour through Zurich Thursday 1 December 2011 Fee* One hour guided tour through Zurich 15.00 Please indicate which Tutorial (page two) you wish to attend: TOTAL AMOUNT DUE: NOTE: PAYMENT IS DUE 30 DAYS AFTER REGISTRATION AND MUST BE PAID IN FULL BY COMMENCEMENT OF THE EVENT GROUP DISCOUNT, SME AND STUDENT RATES ARE AVAILABLE. PLEASE CONTACT THE DIA FOR MORE INFORMATION 11104DIA ATTENDEE DETAILS PlEASE CoMPlETE IN BloCK CAPITAl letters or MAKE registration EvEN SIMPlEr By ATTACHINg THE ATTENDEE S BuSINESS CArD HErE Prof Dr Ms Mr Last Name PAYMENT METHODS - Credit cards are the preferred payment method. Please charge my credit card - Credit card payments by VISA, Mastercard or AMEX can be made by completing the relevant details below. Please note that other types of credit card cannot be accepted. VISA MC AMEX First Name Company Job Title Street Address / P.O. Box Postal Code City Card Number Expiry Date Cardholder s Name Date Cardholder s Signature Country Fax (Required for confirmation) Telephone Email (Required to receive presentation download instructions) Please indicate your professional category: Academia Government Industry Contract Service Organisation Cheques should be made payable to: DIA and mailed together with a copy of the registration form to facilitate identification to: DIA Europe, Elisabethenanlage 25, Postfach, 4002 Basel, Bank transfers: When DIA Europe completes your registration, an email will be sent to the address on the registration form with instructions on how to complete the bank transfer. Payments in EURO should be addressed to Account Holder: DIA. including your name, company, Meeting ID# 11104 as well as the invoice number to ensure correct allocation of your payment. Payments must be net of all charges and bank charges must be borne by the payer. CANCELLATION POLICY: All cancellations must be in writing and received with DIA Europe by 17:00 CET on 22 November 2011 Cancellations received by the date above are subject to an administrative fee: Full Meeting Cancellation: Industry (Member/non-member) = 200.00. Government/Academia/Non-profit (Member/non-member) = 100.00. Tutorial cancellation: 50.00. Regretfully, if you do not cancel by the date above and do not attend, you will be responsible for the full registration fee. you are responsible for cancelling your own hotel reservations. DIA Europe reserves the right to alter the venue and dates if necessary. If an event is cancelled, DIA Europe is not responsible for airfare, hotel or other costs incurred by yourself. Transfer Policy you may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute attendees will be responsible for the non-member fee, if applicable. Please notify DIA Europe office of any such substitutions as soon as possible. IMPORTANT: Hotel and travel reservations should be made ONLY after receipt of written registration confirmation from DIA Europe. If you have not received your confirmation within five working days, please contact DIA Europe. HOW TO REGISTER The DIA Europe Customer Services Team will be pleased to assist you with your registration. Please call us on +41 61 225 51 51 from Monday to Friday between 08:00 and 17:00 CET. Online www.diahome.org Fax +41 61 225 51 52 Email diaeurope@diaeurope.org Mail DIA Europe Postfach, 4002 Basel, DIA 2011