September 23-25, Hotel Fira Palace, Barcelona, Spain

Transcription

1 5th Annual European Electronic Document Management Conference: Exploring Boundaries - Developing Solutions - Managing Globally Dedicated to Your Information & Advancement September 23-25, Hotel Fira Palace, Barcelona, Spain 5th Annual European Electronic Document Management Conference Exploring Boundaries Developing Solutions Managing Globally Programme Co-Chairpersons Steve Scribner, First Consulting Group Inc., USA Programme Committee Mary Collins, ImageSolutions Inc., USA Stuart Cummings, Merck Sharp & Dohme, Belgium John Ferguson, Xerox Corporation, UK Paul Hermans, Pro Text, Belgium Nigel Kirkham, Xansa, USA Vibeke Munksgaard, NovoNordisk, Denmark Mark Sildve, Merck & Co., USA Andreas Staudt, Bayer, Germany Stan van Belkum, Medicines Evaluation Board, The Netherlands ABOUT THE DRUG INFORMATION ASSOCIATION With more than 27,000 members worldwide, the Drug Information Association (DIA) is the premier member-driven organization encompassing the full continuum of disciplines in the pharmaceutical and related industries. The mission of DIA is to serve and develop members by providing a neutral, global forum that promotes the exchange of information critical to their professional performance and achievement. The goal of DIA is to be the most effective means for members to obtain the knowledge they need to advance their career, their profession, and their organization. Conference Objectives The pharmaceutical industry is continually challenged to develop and deliver new processes, to operate globally and must take risks to implement innovative technology solutions. Electronic Document Management has a key role to play in supporting the Worldwide Enterprise and in facilitating productive document management solutions. This year's DIA European Electronic Document Management Conference will provide a forum for active discussion on how to meet the challenges of working within the discipline today, how to implement change and how to know when change has been successful. Considerable emphasis will be on practical experiences with the CTD and e-ctd, e- Submissions, and managing the changes within our organisations. Key themes of the meeting will cover internal and external document exchange, regulatory submissions, the impact of regulations and guidelines, future technology and emerging business environments and opportunities for sharing information using e-commerce solutions. On Monday, September 23rd, conference attendees are invited to participate in tutorials covering e-submission Review and/or XML, or can attend an interactive panel discussion designed to introduce the current state of EDM to those new to the subject. Exhibition In support of the topics of this conference, the DIA will provide the opportunity for organisations to exhibit their products and service offerings. To obtain details on exhibiting space and facilities, interested exhibitors should contact: Drug Information Association - Exhibit Department 501 Office Center Drive, Suite Fort Washington, PA , USA Tel.: Fax: dia@diahome.org

2 5TH ANNUAL EUROPEAN ELECTRONIC DOCUMENT MANAGEMENT CONFERENCE Monday, September 23, Tutorials 09:00-15:00 Tutorial 1 ELECTRONIC SUBMISSION REVIEW: - THE IMPACT ON REGULATORY AUTHORITY PROCESSES Session Mary L. Collins, Image Solutions Inc., USA This tutorial is presented in collaboration with DIA's Global Regulatory Architecture for Submissions Processes (GRASP) Special Interest Area Community on Best Practices and Education. This is a 'must attend' tutorial for companies contemplating submitting electronically, or for those who routinely submit electronically and want a better understanding of the impact on agency review processes. The tutorial faculty, which includes representatives from regulatory authorities in Europe and the United States, will provide presentations and demonstrations of electronic review techniques that will facilitate the learning process. There will be a panel discussion at the end of the tutorial to answer participant questions. Who should attend? - All individuals interested in an "insider's view" of the electronic submission review process. This would include, but not be limited to regulatory affairs and regulatory operation professionals, clinicians, document and data managers, project managers, medical writers, IT and IT end-users and support personnel. Lunch will be served from 12:00-13:00 What will you learn? - Current Status of electronic submissions in Europe and the United States Technology Reviewer training Impact of technology on the review process. - The CTD How to submit electronically (the interim) ectd - How close are we? The impact on the review process. Tutorial faculty: Randy Levin, FDA, Pieter Neels, CPMP, Belgium, Timothy Mahoney, FDA, Armando Oliva, FDA, Stan Van Belkum, Medicines Evaluation Board, The Netherlands. DIA Best Practices & Education Coordinators: Mary L. Collins, Image Solutions, Inc. and Nancy Smerkanich, Octagon Research. 15:30-18:00 Parallel Tutorial 2 XML AND THE REGULATORY PROCESS Session Jon Clark, FDA, USA This tutorial is presented in collaboration with DIA's Global Regulatory Architecture for Submissions Processing (GRASP) Special Interest Area Community on Best Practices and Education. XML continues to be one of the "Hot Topics" in the area of electronic regulatory document management and review. This is an opportunity to gain an understanding of the technology and how it is being applied to the regulatory process. Who should attend? - This tutorial is designed for persons interested in an understanding of the application of XML to the regulatory process and who have little or no knowledge of XML. This would include, but not be limited to regulatory personnel, clinicians, document and data managers, project managers, medical writers, IT and IT end-user support personnel. What will you learn? - Participants will learn the fundamentals of XML and how it is impacting the regulatory process through presentation and demonstration. At the conclusion of this tutorial, participants will have an understanding of, and answers to: 15:30-17:30 Parallel Tutorial 3 INTRODUCTION TO ELECTRONIC DOCUMENT MANAGEMENT Facilitators: Melanie Clare, GlaxoSmithKline UK and Steve Scribner, FCG, USA What is a document? What is meant by the 'lifecycle' or the 'promotional model' of a document? Why does a document need to have attributes? What is workflow and how does that help me get my job done? How do government regulations impact document management practices? What are the implications of the ICH Common Technical Document for industry and agency? What are all these strange terms and acronyms? Do I need to know them? A panel of experts will be available to introduce these topics and answer questions - in an informal forum - to those wishing to clarify Electronic Document Management. Those new to the topic will be in a better position to follow the themes of the conference that follows - and will benefit after the meeting in being able to place newly acquired information into context. What is XML? What are DTDs, elements, attributes and entities? How are they used? How will XML be applied to the ectd? How might XML be applied in the future? Demonstrations will include using XML to create the ectd "backbone". Examples of XML applications will also be presented so that attendees can evaluate ease of use from the end-user perspective. Tutorial faculty: Terry Hardin, IBM, USA, Stan van Belkum, Medicines Evaluation Board, The Netherlands, Jon Clark, FDA Note: If you attend the Introduction to EDM Tutorial, please indicate a key topic that you would be particularly interested in to discuss (see Registration Form on last page) DIA Best Practices & Education Coordinator: Mary L. Collins, Image Solutions, Inc.

3 SEPTEMBER 23-25, HOTEL FIRA PALACE, BARCELONA, SPAIN Tuesday, September 24, Conference & Exhibition 09:00 Opening Plenary Steve Scribner, First Consulting Group, Inc., USA DIA Welcome Stuart Cummings, Merck Sharp & Dohme (Europe) Inc., Belgium Conference Welcome This year's DIA European Electronic Document Management Conference will provide a forum for active discussion on how to meet the challenges of working within the discipline today, how to implement change and how to know when change has been successful. The conference will cover: the transition of regulatory submissions from CTD to ectd internal and external document exchange electronic document/submission preparation and review measuring success emerging business environments technologies for sharing information using e-solutions business case studies including the use of Electronic Laboratory Notebooks (ELN), and approaches to GMP and compliance. The progress of the PIM project will also be presented. Together with the opportunity to get involved in discussion with a wide range of expert speakers, the programme will provide up to date information on a comprehensive range of electronic document management topics to help Explore Boundaries, Develop Solutions and Manage Globally - the key themes of this conference. 09:15 Opening Keynote Speaker to be announced 10:00 CTD to ectd - EFPIA Update Andrew P. Marr, EFPIA, GlaxoSmithKline, UK The Step 4 should be agreed at the ICH Steering Committee meeting in Washington, September Step 4 is the penultimate step before implementation. There will no doubt be changes from the Step 2 document which is currently out for review. The presentation will define what changes have been made. It will identify the potential business impacts of the adoption of the specification by industry and the areas on which there still needs to be agreement to allow implementation in each region. 10:30 Coffee Break 11:00 Electronic Document Management: Regulatory Authority Perspectives Andreas Staudt, Bayer, Germany Regulatory authorities have been working diligently with the ICH, pharmaceutical industry representatives, and service providers to meet the challenges of the new electronic paradigm. This session will explore some of the agency initiatives and explain how they may affect regulatory processes in the future. Stan Van Belkum, Medicines Evaluation Board, The Netherlands Randy Levin, FDA, USA Jon Clark, FDA, USA 12:30-14:00 Buffet Lunch in the Exhibition Area 14:00 Session 1 Track A ( parallels Session 1 Track B) Global Dossier Stan van Belkum, Medicines Evaluation Board, The Netherlands The ICH standardisation process around the electronic version of the Common Technical Document is almost finalised. Now it is the time to initiate the implementation of the XML standard into the complex dossier compilation processes. In this session an overview will be presented on the general ectd implementation status in the EU and examples will be given of practical experience with the preparation of pharmaceutical dossiers in ectd format. The ectd: Status and Progress of Implementation Said Ikazban, Merck Sharp & Dohme (Europe) Inc., Belgium Sign-off stage of the specification documents Implementation aspects of Modules 2-5 Implementation aspects for Module 1 and other regional components Practical aspects of implementation Lifecycle management issues A First Step into the Direction of the ectd: Industry and Agency Experience Dietmar Boecker, Bayer AG, Germany Operational Experience with a Centralized Procedure Application Compilations Strategy Challenges during the Compilation and what we have learned on both sides Preparing an ectd Hans Verbruggen, Yamanouchi Europe B.V., The Netherlands CTD content differences in the US and EU: Quality Module and Product Information How to organise preparation of two ectds using one structure, but different content How Yamanouchi Compiles and Publishes ectds 14:00 Session 1 Track B (parallels Session 1 Track A) Future Collaboration Opportunities (Part 1) Mark Sildve, Merck & Co, USA Recent successes resulting from industry and agency collaborative initiatives have encouraged us to think differently about how we create, deliver, and access information. This session, as well as Session 2, Track B, challenges our current content management boundaries within sponsor, regulator, and consumer. Our speakers will share experiences and insights that will provoke your thinking as we seek opportunities to improve information sharing in the future. Shared Responsibilities between Sponsors and Regulators Olaf Schoepke, CDC Solutions Ltd., UK Introduction to Trusted 3rd Party Repository (Demonstration) Terry Hardin, IBM, USA Over the past several years there has been much discussion regarding ways to improve the submission process for new drug applications and investigations. These discussions centre on ways for the pharmaceutical industry and drug regulatory agencies to move from a paper based submission process to a more efficient electronic model. The industry and regulatory agencies must move away from the "text-oriented" model to an "intelligent data" model where not only the data but the submission process itself can be completed entirely in electronic form. The solution is to use the Internet combined with an "online" Trusted 3rd Party Repository (T3PR) that maintains highly secure information to support a collaborative environment for the sponsors and the regulatory agencies involved in an interactive review process. 15:30-16:00 Coffee Break 15:30-16:00 Coffee Break

4 5TH ANNUAL EUROPEAN ELECTRONIC DOCUMENT MANAGEMENT CONFERENCE 16:00 Session 2 Track A (parallels Session 2 Track B) EDM - Making the Workflow Work - Practical Lessons Learned Nigel Kirkham, Xansa, USA This session will take us back to the basics by showing, through practical examples, how people, process and technology can be managed to ensure document management systems are implemented as part of an overall workflow. Three very different speakers will show us how they have tackled such change from an IT, systems integration, business process, and people change perspective. Practical case studies will be described throughout. The Consultant's Perspective of Implementing EDM Processes in Global Pharmaceutical Companies. Lisa Valentine, First Consulting Group, USA The issues that small biotech and pharma companies, as well as start-ups face when they embark on EDM implementations without the budgets or requirements for large-scale solutions. Alan Birks, Consignit Ltd, UK 16:00 Session 2 Track B (parallels Session 2 Track A) Future Collaboration Opportunities (Part 2) Mark Sildve, Merck & Co, USA Recent successes resulting from industry and agency collaborative initiatives have encouraged us to think differently about how we create, deliver, and access information. This session challenges our current content management boundaries within sponsor, regulator, and consumer. Our speakers will share experiences and insights that will provoke your thinking as we seek opportunities to improve information sharing in the future. Collaboration to Benefit the Patient Steve Mott, Datapharm Communications Ltd, UK Customer Relationship Management meets Document Management: Integrating the Technologies for Better Solutions Delivery Marty Magazzolo, First Consulting Group, USA Speaker to be announced Managing Complexity on a Global Implementation of EDM at Bayer AG Andreas Staudt, Bayer AG, Germany 17:30 DIA Reception and Exhibitors Open House The reception will be held in the Exhibits area with plenty of time for conference attendees to visit vendor displays. 21:00 Conference Dinner and Social Evening Open to all Conference attendees. It has become traditional at the EDM Conference for attendees to participate at an optional evening event, reasonably priced, and with a focus on local culture, and emphasis on informality. This year a limited number of places have been reserved in a very special atmosphere. This event will take place on Tuesday, September 24, More detailed information will be available on site. Tickets will be sold on a first-come first-serve basis at the DIA registration desk on Sunday, Monday and Tuesday morning, until the end of the morning coffee break. In view of the limited number of places that are reservable, attendees are recommended to secure their tickets at the time of registration at an additional charge of EURO 60.- per person. Wednesday, September 25, Conference & Exhibition 09:00 Session 3 Track A (parallels Session 3 Track B) Collaboration Tools John Ferguson, Xerox Corporation, UK In a complex environment where many people are working together to develop or finalise key documents too often we find ourselves limited by the tools we are using. This session looks at how we can improve collaboration using new and better tools. The outcome of which is better documents, more time for other tasks and perhaps more important less stress. A Project Space Portal: Enhancing Drug Discovery and Development through Collaborative Knowledge Shairng and Information Access Peg Mitchell, Aventis, USA Electronic Library and Information Management System - Case Study & Demo Henning.P.Nielsen, Novo Nordisk, Denmark A prescription for Collaboration Tracey Miller, Workshare, UK 10:30-11:00 Coffee Break 09:00 Session 3 Track B (parallels Session 3 Track A) Research & Discovery Vibeke Munksgaard, Novo Nordisk, Denmark Laboratory Notebooks on paper have been an integrated part of laboratory work in the pharmaceutical industry for decades. During the last few years many companies have investigated or even implemented electronic systems such as Electronic Laboratory Notebooks (ELN) or Laboratory Operating Procedure (LOP) applications for record keeping, in order to facilitate the sharing, or finding of, relevant information within research units. This session provides practical information from industry case studies that show how applications have been developed in close collaboration with the research institute. Electronic Laboratory Notebook at Novo Nordisk - Development & Use Gorm Jesper Kruse, Novo Nordisk A/S, Denmark Laboratory Notebook Bernard Dienon, Roche Laboratory Operating Procedures Lars Johannesen, Bayer AG, Germany 10:30-11:00 Coffee Break

5 SEPTEMBER 23-25, HOTEL FIRA PALACE, BARCELONA, SPAIN 11:00 Session 4, Track A (parallels Session 4, Track B) Business Cases Stuart Cummings, Merck, Sharp & Dohme (Europe) Inc., Belgium As organisations seek to define and implement e-document technology and management solutions across the enterprise, developing the business case and emphasizing the business benefits has never been more essential. The first part of this session will focus on theoretical and practical considerations in building the business case and quantifying the return on investment (ROI). Building the Business Case for Electronic Content Management Systems Jonathan Burd, FCG, UK The Added Value of edocument Management Solutions. Theory and Practice Dirk Ehrhard, Boehringer Ingelheim, Germany Metrics - The Challenges of Making Real and Relevant Numbers Mark Sildve, Merck & Co, USA 11:00 Session 4, Track B (parallels Session 4, Track A) GMP & Compliance Andreas Staudt, Bayer, Germany This session will higlight the challenges of Electronic Document Management implementations and how to achieve compliance with pertinent regulations in the GMP area. Speakers will share their experience in meeting the challenge, the impact on their company, and the benefits realised to-date. Implementing a GMP Document Management Solution Michael Eyraud, Aventis, France Controlled Document Management - a Case Study Speaker to be announced Digital Packaging Components: Achieving Speed of Production of Country- Specific Labelling Marianne Kock, Novo Nordisk, Denmark This presentation is given in collaboration with DIA's Global Regulatory Architecture for Submissions Processing (GRASP) Special Interest Area Community on Metrics. 'Gathering metrics' is a challenging and mercurial process! So much so, that companies often choose to measure what is 'easiest' - or avoid the challenge altogether. Why do we need metrics in the world of electronic documents and submissions? What metrics make a difference? How do we know what's good enough in the way in which electronic documents and submissions are prepared and reviewed? 12:30-14:00 Buffet Lunch in the Exhibition Area 12:30-14:00 Buffet Lunch in the Exhibition Area 14:00 Plenary Regulatory Agency Electronic Review Mary Collins, ImageSolutions Inc., USA Tremendous progress has been achieved in the last decade in the area of electronic regulatory submissions, both by industry and regulatory authorities. This session will provide insight on the readiness of authorities to receive electronic submissions and further, will assess the impact of e-subs on the review process. David Wheeler, MCA, UK Armando Oliva, FDA, USA 15:30 Plenary (Cont d) PIM - Phase 2 Proof of Concept Project Steve Scribner, FCG, USA This session will focus on showcasing the results of the PIM Phase 2 proof of concept project. This will include a demonstration of the PIM processes, information structure and systems that have been agreed upon during Phase 2. This presentation will describe how the phase 2 project was conceived and formulated. It will also signal the route forward for industry and authorities to implement and adopt PIM as part of ectd. Stephen Adshead, AstraZeneca, UK Agency speaker invited Questions & Answers 15:15-15:30 Coffee Break 16:45 Closing Remarks 17:00 Conference Closed

6 Hotel & Travel Information The DIA has blocked a number of rooms at the: Hotel Fira Palace, Avinguda Rius i Taulet, Barcelona, Spain telephone: or fax: or reception@fira-palace.com Conference Registration Form 5th Annual European Electronic Document Management Conference: Exploring Boundaries - Developing Solutions - Managing Globally Hotel Fira Palace, Barcelona, Spain - September 23-25, 2002 I.D. # Please consider this form an INVOICE - Registration will be accepted by mail, fax or REGISTRATION FEE** * * If DIA cannot verify your membership, you will be charged the nonmember fee Registration includes workshop material, coffee-breaks and luncheons at the special rate of: Standard Double Room: Euro Standard Double Room for Single use: Euro Superior Double Room: Euro Superior Double Room for Single Use: Euro Above rates are per room, night, including Buffet Breakfast, excluding 7% VAT. Attendees must make their own hotel reservation by fax or by referring to the DIA EDM Conference A deposit payment for one night must be made to secure the reservation by providing, with signature, the name, number and expiry date of your credit card. IMPORTANT: To be assured of accommodation in the HotelFira Palace, registrants are recommended to complete their reservation, if possible, by August 12, Member** EURO Nonmember EURO Government & Academia (Full-Time), Member ** EURO Government & Academia (Full-Time), Nonmember EURO I will attend the Social Event EURO 60.- Tutorial 1 EURO Tutorial 2 EURO Tutorial 3* FREE * If you attend the Introduction to EDM Tutorial (Tutorial 3), please indicate a key topic that you would be particularly interested in to discuss: Please tick the applicable category: Academia Government Industry CSO Student Registrant Fax or mail your completed registration form to your nearest DIA Office Professor Dr. Ms. Mr. Last Name First Name Middle Initial GROUP DISCOUNTS AVAILABLE! Register 3 individuals from the same company location and the 4th attends FREE! All 4 individuals must be registered at the same time. Substitutions of enrolled delegates may be made at any time. The complimentary registration for the 4th attendee applies only to the registration fee which includes refreshment breaks, luncheons and receptions. It does not include any optional events such as tutorials, tours or networking dinners nor does it include DIA membership. Affiliation Job Title Street Address / P.O. Box Postal Code Country City To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company location and return them together to DIA. Please indicate that this form is part of a group registration by ticking this box. Please indicate the full names of the other three registrants from your company location (must represent the same company location as registrant #1) 2. Name 3. Name 4. Name (*)Telephone (*)Telefax (*) A telephone and fax number are required for faxed confirmation Payment Cheques should be made payable to: Drug Information Association. Mail your cheque together with the registration form to facilitate identification of attendee to: DIA, Postfach, 4002 Basel, Switzerland. Bank transfers should be made in EURO to: UBS, Postfach, 4002 Basel, Switzerland - DIA Account Number: C Your name and company must be included on the transfer document to ensure payment to your account. Credit card payments by VISA, Mastercard or American Express can be made by completing the relevant details hereunder. Visa MC AMEX Card Number Exp. date: Cardholder s Name European Office Postfach, 4002 Basel, Switzerland Tel.: Fax: diaeurope@diaeurope.org USA Office 501 Office Center Drive, Suite Fort Washington, PA Tel.: Fax: dia@diahome.org Cardholder s Signature Please indicate method of payment: Cheque Workshop Cancellation Policy On or before September 19, 2002 An administrative fee will be deducted from the registration fee: Member and Nonmember = EURO Government & Academia (Member/Nonmember) = EURO Bank transfer Japan Office Level 32 - Shinjuku Nomura Building Nishi-Shinjuku-ku, Tokyo , Japan Tel.: Fax: diajapan@gol.com Registrants who do not cancel by the date above and do not attend, will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel reservations. Cancellations must be in writing. You may transfer your registration to a colleague at any time. Please notify DIA of any such substitutions as soon as possible. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for airfare, hotel or other costs incurred by registrants.