12th Conference on European Electronic Document Management

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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.

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

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: [email protected]

Programme Co-Chairs

Dimitri Stamatiadis, Director Management Processes, Merck Serono, Switzerland 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

Melanie J. Clare, Global Head, Clinical Document Management & Publishing, GlaxoSmithKline, USA Joris Kampmeijer, Head of Information Processing, Medicines Evaluation Board, The Netherlands Anita Paul, Head of Corporate Records Management, F. Hoffmann-La Roche AG, Switzerland

Continuing Education

The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this conference with 12 credits.

Event #11104

30 November - 2 December 2011

Swissotel, Zurich, Switzerland

Electronic Document Management

New Practices beyond Document Management

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

Tutorial 3:

DOCUMENT MANAGEMENT, EARCHIVING, RECORDS MANAGEMENT: FROM GOOD TO GREAT - A PRACTICUM BEyOND DOCUMENT MANAGEMENT

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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, UK Karen redding, Business Development Director, Phlexglobal Ltd, UK

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:

russell Joyce, Director & Principal Consultant, Heath Barrowcliff Consulting Ltd, UK 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

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, Switzerland

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, Switzerland

eSubmissions in Crop science

Felix Meier-Manz, Lead CP Regulatory Knowledge, Management and Support, Syngenta Crop Protection AG, Switzerland 10:30 CoFFEE BrEAK IN THE EXHIBITIoN ArEA

PRE-CONfERENCE fUll DAY TUTORiAlS ON WEDNESDAY, 30 NOvEMBER 2011

10:30 - 11:00 CoFFEE BrEAK 12:30 - 14:00 luNCH BrEAK 15:30 - 16:00 CoFFEE BrEAK

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11:00 SESSIoN 2

SuBMISSIoNS IN A gloBAl ENvIroNMENT

Session Chairperson:

Joris Kampmeijer, Head of Information Processing, Medicines Evaluation Board, The Netherlands

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 specific dossier. Even if it concerns country-specific 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?

lessons learnt with global submissions

Joerg Schnitzler, Associate Director Regulatory Operations, Regulatory Affairs Europe, Astellas Pharma Europe R&D

11:00 PArAllEl SESSIoN 2

CoNSIDErATIoNS For SETTINg uP AN eTMF

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, UK Experience with eTMFs and Investigative Site Archiving

Michael Smyth, General Manager Life Sciences Solutions, TransPerfect, UK

12:30 luNCH IN THE EXHIBITIoN ArEA 14:00 SESSIoN 3

AgENCy uPDATE

uSA

Gary Gensinger, Deputy Director, Office of Business Informatics, Center for Drug Evaluation and Research, FDA, USA

The Netherlands

Rob de Haan, MEB Representative at Telematics Implementation Group for electronic submission (TIGes) and EU Representative at ICH M2

Switzerland

Urs A. Niggli, Head, Support Marketing Authorisations, Swissmedic, Switzerland

14:00 PArAllEl SESSIoN 3 eTMF SPECIAl INTErEST ToPICS

Eldin rammell, Managing Director, Rammell Consulting Limited, UK 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, UK

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, USA & Steve Scribner, Managing Consultant, International Life Science Solutions, USA

Presentation eTMF – Inspector’s perspective Andrew Fisher, Senior GCP Inspector, MHRA, UK

THURSDAY | 1 DECEMBER, 2011 | PARAllEl SESSiONS

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 Informatics, Center for Drug Evaluation and Research, FDA, USA

• Joris Kampmeijer, Head of Information Processing, Medicines Evaluation Board, The Netherlands

• 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,

Switzerland

16:00 PArAllEl SESSIoN 4 TMF rouND TABlE

Anita Paul, Head of Corporate Records Management, F. Hoffmann-La Roche AG, Switzerland

Panellists:

• Russell Joyce, Director & Principal Consultant, Heath Barrowcliff Consulting Ltd, 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 • Eldin Rammell, Managing Director, Rammell Consulting Limited, UK 17:30 DrINKS rECEPTIoN IN THE EXHIBITIoN ArEA

18:30 guIDED Tour THrougH ZurICH 19:30 END oF DAy oNE

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10:30 SESSIoN 6

rEgISTrATIoN TrACKINg

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.

gSM 2.0: Implementation Considerations

Amanda Keller, Senior Process Consultant – Europe, Octagon Research Solutions Ltd., UK

Industry Submission registration Information for Compliance Cynthia F. Piccirillo, Director, Global Dossier Management eStrategy, Bristol-Myers Squibb Company, USA

Preparing and Tracking Submissions and Approvals globally

Nancy Vermeiren, Director Global Regulatory Affairs – GRA-CMC, Janssen Pharmaceutica NV, Belgium

ClINICAl rESEArCH orgANISATIoNS (Cros) AND SMAll & MEDIuM SIZE ENTErPrISES (SMEs)

Hans van Bruggen, Senior Regulatory Affairs Consultant, eCTDconsul-tancy, The Netherlands

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, Switzerland

Implementing a corporate DMS in a mid size company: The transition to information management

Esther O’Driscoll, Group Leader EDMS, Actelion Pharmaceuticals Ltd., Switzerland

fRiDAY | 2 DECEMBER 2011

08:00 WElCoME CoFFEE IN THE EXHIBITIoN ArEA 08:30 SESSIoN 5

eDM NoW AND BEyoND

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, 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

Sanne Godiksen, Project Manager & Senior Business Consultant, Life Science Division, NNIT A/S, Denmark

10:00 CoFFEE BrEAK IN THE EXHIBITIoN ArEA

12:00 luNCH IN THE EXHIBITIoN ArEA

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

Exhibiting Companies

Company Country NextDocs USA CSC USA

DoubleBridge Technologies, Inc. USA

Exalon GmbH Germany

EXTEDO Germany

fme AG Germany

Liquent USA

LORENZ Life Sciences Group Germany

Montrium Canada

Company Country

NNIT A/S Denmark

Octagon Research Solutions Ltd UK Phlexglobal Limited UK Product Life AG Switzerland

QUMAS Ireland

TransPerfect USA

Veeva Systems USA

Wingsplan Technology, Inc. USA

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13:30 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, President, ING America, Inc., USA

IrISS lifecycle Topic group – options for the presentation of eCTD messages

Alastair Nixon, Director, Submission Publishing, GlaxoSmithKline, UK

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, Partner, IFEMA - Institue for Effective Management, Germany

good Management Practice (gMP) Controlled Documents Throughout a Merger

Wolfgang Schumacher, Head of Pharma Technical Quality Computer Systems, Roche, Switzerland

15:30 SESSIoN 8

DITA AND eSIgNATurE

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, UK

Structured Product Information with DITA – A well established XMl standard since 2004 Christian Kravogel, Product Manager, EXTEDO GmbH, Switzerland

CloSINg oF CoNFErENCE

Dimitri Stamatiadis, Project Director, Merck Serono, Switzerland 15:00 CoFFEE BrEAK IN THE EXHIBITIoN ArEA

16:30 END oF CoNFErENCE

fRiDAY | 2 DECEMBER 2011

Hotel information

DIA Europe has blocked a limited number of rooms at the: Swissotel Zürich Am Marktplatz Oerlikon Schulstrasse 44 CH-8050 Zürich Switzerland 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.

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ATTENDEE DETAILS

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Payments must be net of all charges and bank charges must be borne by the payer.

12th Conference on European Electronic Document Management

30 November - 2 December 2011 | Swissotel, Zurich, Switzerland

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

HOW TO REGISTER

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.

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-profi t (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 offi ce of any such substitutions as soon as possible.

IMPORTANT:

Hotel and travel reservations should be made ONLY after receipt of written registration confi rmation from DIA Europe

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If you have not received your confi rmation within fi ve working days, please contact DIA Europe.

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.

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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-profi t members

11104DIA

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: ___________

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-profi t/Academia (Full-Time) € 683.00  € 798.00 