12th Conference on European Electronic Document Management

Transcription

1 12th Conference on European Electronic Document Management New Practices beyond Document Management Event # November - 2 December 2011 Swissotel, Zurich Programme Co-Chairs Dimitri Stamatiadis, Director Management Processes, Merck Serono, Hans van Bruggen, Senior Regulatory Affairs Consultant, ectdconsultancy, The Netherlands Programme Committee Thomas Altenwerth, Head of Global Regulatory Affairs Archives Wuppertal, Bayer HealthCare Pharmaceuticals, Germany 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, USA Joris Kampmeijer, Head of Information Processing, Medicines 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 :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 or natacha.scholl@diaeurope.org Tutorial 2: ELECTRONIC SUBMISSIONS: WALK BEFORE YOU RUN! Tutorial 3: DOCUMENT MANAGEMENT, RECORDS MANAGEMENT, EARCHIVING: FROM GOOD TO GREAT - A PRACTICUM BEYOND DOCUMENT MANAGEMENT

2 2 PRE-CONFERENCE FULL DAY TUTORIALS ON WEDNESDAY, 30 NOVEMBER :30 ARRIVAL & REGISTRATION Tutorial 1 09:00 17:00 etmf - MIGRATING FROM PAPER TRIAL MASTER FILES TO ELECTRONIC Tutorial Co-Instructors: Karen Redding, Business Development Director, Phlexglobal Ltd., UK Tutorial 2 09:00 17:00 ELECTRONIC SUBMISSIONS: WALK BEFORE YOU RUN! Tutorial Co-Instructors: Evaluation Board, The Netherlands Hans van Bruggen, Senior Regulatory Affairs Consultant, ectdconsultancy, The Netherlands Tutorial 3 09:00 17:00 DOCUMENT MANAGEMENT, RECORDS MANAGEMENT, earchiving: FROM GOOD TO GREAT - A PRACTICUM BEYOND DOCUMENT MANAGEMENT Tutorial Co-Instructors: Thomas Altenwerth, Head of Global Regulatory Affairs Archives Wuppertal, Bayer HealthCare Pharmaceuticals, Germany Anita Paul, Head of Corporate Records Management, F. Hoffmann-La Roche AG, 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, The Netherlands 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, Additional presenter invited 10:30 COFFEE BREAK IN THE EXHIBITION AREA About the DIA The DIA is a neutral, global, professional, member-driven association of nearly 18,000 biotechnology, pharmaceutical, clinical or medical, academic and regulatory professionals, students and patient representatives. Through its international meetings, training courses, online learning and myriad networking opportunities, the DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel,, Tokyo, Japan, Mumbai, India, and Beijing, China. For more information, visit or call the DIA in Europe

3 3 THURSDAY 1 DECEMBER, 2011 PARALLEL SESSIONS 11:00 SESSION 2 SUBMISSIONS IN A GLOBAL ENVIRONMENT This session is currently in development 11:00 PARALLEL SESSION 2 CONSIDERATIONS FOR SETTING UP AN etmf Thomas Altenwerth, Head of Global Regulatory Affairs Archives Wuppertal, Bayer HealthCare Pharmaceuticals, Germany 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 Franciska Darmer, EMEA Life Science Solution Specialist, CSC Life Sciences, Denmark Experience with etmfs and Investigative Site Archiving Michael Smyth, General Manager Life Sciences Solutions, TransPerfect, UK TMF Reference Model Leveraging for success Karen Redding, Business Development Director, Phlexglobal Ltd., UK 12:30 LUNCH IN THE EXHIBITION AREA 14:00 SESSION 3 AGENCY UPDATE Hans van Bruggen, Senior Regulatory Affairs Consultant, ectdconsultancy, The Netherlands USA Gary Gensinger, Deputy Director, Office of Business Process Support, Center for Drug Evaluation and Research, FDA, USA The Netherlands Swissmedic representative invited UK Government representative invited 14:00 PARALLEL SESSION 3 etmf SPECIAL INTEREST TOPICS 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 s into the Trial Master File Sarah Hitching, Director, Records Management, Chiltern, UK Destruction of Paper Position of the DIA SIAC Lisa D. Mulcahy, TMF Document Management Consultant, Mulcahy Consulting, LLC, USA Presentation etmf Inspector s perspective Andrew Fisher, Senior GCP Inspector, MHRA, UK 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, USA Panellists: Gary Gensinger, Deputy Director, Office of Business Process Support, Center for Drug Evaluation and Research, FDA, USA Swissmedic representative invited Government representative invited 16:00 PARALLEL SESSION 4 TMF ROUND TABLE Anita Paul, Head of Corporate Records Management, F. Hoffmann-La Roche AG, Panellists: Sarah Hitching, Director, Records Management, Chiltern, UK Lisa D. Mulcahy, TMF Document Management Consultant, Mulcahy Consulting, LLC, USA Andrew Fisher, Senior GCP Inspector, MHRA, UK Karen Redding, Business Development Director, Phlexglobal Ltd., UK 17:30 DRINKS RECEPTION IN THE EXHIBITION AREA 18:30 GUIDED TOUR THROUGH ZURICH 19:30 END OF DAY ONE

4 4 FRIDAY 2 DECEMBER :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 Industry Benchmark in Enterprise Content Management and Collaboration Strategy Steve Scribner, Principal Consultant, International Life Science Solutions, Inc., USA Small Company Perspective The cloud is the answer, the sky is the limit Kate Wilber, Senior Product Manager, Veeva Systems Inc., USA Collaboration Beyond the Firewall Thomas Hornbaek Svendsen, Principal 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, Germany 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. Industry Submission Registration Information for Compliance David S. Ross, Associate Director, Regulatory Affairs, Submission Process Area Lead, AstraZeneca Pharmaceutical LLP, USA Preparing and Tracking Submissions and Approvals Globally Nancy Vermeiren, Director Global Regulatory Affairs CMC, Johnson & Johnson, The Netherlands Additional presenter invited 10:30 PARALLEL SESSION 6 CLINICAL RESEARCH ORGANISATIONS (CROs) AND SMALL & MEDIUM SIZE ENTERPRISES (SMEs) Anita Paul, Head of Corporate Records Management, F. Hoffmann-La Roche AG, 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. Leveraging Cloud-Based Solutions for the Exchange of Critical Documents in Clinical Trial Management Jason Hemingway, Marketing Manager EMEA, Intralinks Ltd., UK Small Enterprise CRO Perspective on eclinical Documentation Rolf Marugg, Head Drug Regulatory Affairs, Appletree AG, Compliance Snapshots on Systems for SMEs Nathalie Briffod, Records Manager & Archivist, Kuros Biosurgery AG, 12:30 LUNCH IN THE EXHIBITION AREA Exhibiting Companies as of 10 June 2011 Company Country NextDocs USA LORENZ Life Sciences Group Germany EXTEDO Germany Exalon GmbH Germany Product Life AG NNIT A/S Denmark DoubleBridge Technologies, Inc. USA fme AG Germany 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 5 FRIDAY 2 DECEMBER :30 SESSION 7 IRISS On-Going Progress of the IRISS Forums Andrew P. Marr, Managing Director, Marr Consultancy Limited, UK ETICS III The IRISS ectd Tools Interoperability and Compliance Study Harv W. Martens, Vice President of Operations, North America & Japan, EXTEDO, Inc., USA IRISS Lifecycle Topic Group Options for the presentation of ectd messages Alastair Nixon, Director, Submission Publishing, GlaxoSmithKline, UK 13:30 PARALLEL SESSION 7 MERGERS & ACQUISITIONS Melanie J. Clare, Global Head, Clinical Document Management & Publishing, GlaxoSmithKline, USA 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., USA Buy 3 - Get 1: Migration of 3 submission management systems into 1 Adam Aparicio, Senior Director Head Global Regulatory Operations, Merck KGA, Germany 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 Session Co-Chairpersons: Hans van Bruggen, Senior Regulatory Affairs Consultant, ectdconsultancy, The Netherlands esignatures throughout the Lifecycle Structured Product Information with DITA A well established XML standard since 2004 Christian Kravogel, Product Manager, EXTEDO GmbH, 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: Fax: at the special rate of CHF single occupancy including service and VAT but excluding CHF 2.50 city tax. Full American breakfast is at CHF per person. To reserve a room, click on the link: IMPORTANT: To be assured of accommodation at Swissotel Zürich, registrants are recommended to complete their reservation by 21 September 2011 latest.

6 REGISTRATION FORM 12th Conference on European Electronic Document Management 30 November - 2 December 2011 Swissotel, Zurich, ID # 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 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)* Tutorial Wednesday, 30 November 2011 Fee* Tutorial Fee Please indicate which Tutorial (page two) you wish to attend: Join DIA now to qualify for the member rate CATEGORY Member (after 18 October 2011) Fee* Non-Member Fee* Industry Government/Charitable/Non-profit/Academia (Full-Time) * All fees will be subject to the local Swiss VAT at 8% 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 11104DIAWEB 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 Card Number Job Title Expiry Date Street Address / P.O. Box Cardholder s Name Postal Code City Date Cardholder s Signature Country Fax (Required for confirmation) Telephone 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, (Required to receive presentation download instructions) For company billing, please add your company s VAT number: If you wish to be billed privately, please contact our Customer Services Team, as below Please indicate your professional category: Academia Government Industry Contract Service Organisation Bank transfers: When DIA Europe completes your registration, an 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# 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) = Government/Academia/Non-profit (Member/non-member) = Tutorial cancellation: 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 from Monday to Friday between 08:00 and 17:00 CET. Online Fax diaeurope@diaeurope.org Mail DIA Europe Postfach, 4002 Basel, DIA 2011