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Conference Overview

In an evolutionary environment, it seems that every time one overcomes a hurdle one discovers a whole

new world to conquer. Similarly, in EDM we now discover the new frontiers: Electronic gateways and

advanced submission standards such as CDISC and RPS that extend the capabilities and flexibility of

information exchange, new approaches for Enterprise Information Management, simpler and more

affordable tools allowing compliant EDM for small corporations, collaborative and component-based

authoring and new, powerful user interfaces are only some of the emerging novelties. Information

sharing in the public domain has reached previously unthinkable levels and new techniques of

information management are needed to handle both the disclosure and analysis of this new informationeldorado.

On the regulatory submissions front, CTD and eCTD are now well known and understood and thousands

of submissions are now managed as eCTDs. Within stable EDM technologies, is this it? Have we solved

all eCTD questions? What now for EDMS?

Join the 11th DIA Conference on European Electronic Document Management to hear from the pioneers

of this new conquest and become part on the adventure at the new frontiers.

Learning Objectives

At the conclusion of this conference, participants will get an in depth understanding of:

• Operating and implementing EDMS technologies

• Leveraging technologies for quality and efficiency

• Best practices in managing the document lifecycle

• Distinctions between Electronic Document Management and Electronic Information Management

• Using metadata standards in the use and re-use of regulatory information

• XML developments and XML implementation

• Preparing eCTD filings for different European procedures

• 2010 into 2011 - Current agency experience and requirements

• Current and future submission formats

Who Should Attend

• Document and eRecords Managers

• Standards Implementation Specialists and Associates

• Regulatory Affairs Representatives

• Regulatory/Clinical Operations Representatives• Quality Assurance and Compliance Professionals

• Medical & Technical Writers

• IT and Support Personnel

• Contract Researchers and Service Support Providers

• Academic Researchers

• Validation Professionals

• Pharmacovigilance Professionals

• Knowledge/IP Professionals

ExhibitionLast year’s EDM conference attracted delegates from 15 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 healthcaredelivery. To obtain more details on exhibiting space and facilities, please contact Natacha Scholl at the

DIA on +41 61 225 51 59 or email [email protected]

Programme Co-Chairs

Melanie J. Clare

Center for Clinical Study Excellence,

GlaxoSmithKline

Dimitri Stamatiadis

Project Director, Merck Serono, Switzerland

Programme Committee

Thomas Altenwerth

Global Submission Management and Archiving,

Bayer Schering Pharma, Germany

Joris Kampmeijer

Head of Information Processing,

Medicines Evaluation Board, The Netherlands

Anita PaulHead of Corporate Records Management,

F. Hoffmann-La Roche AG, Switzerland

Hans van Bruggen

Senior Regulatory Affairs Consultant,

eCTDconsultancy, The Netherlands

CreditsThe Swiss Association of Pharmaceutical

Professionals (SwAPP) and the Swiss Society for

Pharmaceutical Medicine (SGPM) have accreditedthis meeting with 12 credits.

Event #101101-3 December 2010Le Méridien, Nice, France

11th Conference on European ElectronicDocument Management

The New Frontiers

Full Day Pre-Conference Tutorialson Wednesday, 1 December 2010

Tutorial 1eTMF - MIGRATING FROM PAPER TRIAL MASTER

FILES TO ELECTRONIC

Tutorial 2

eSUBMISSION – A HIGHLIGHT OF THE

DIFFERENCES



WEDNESDAY | 1 DECEMBER 2010

PRE-CONFERENCE TUTORIALS

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 founda-

tion 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

At the conclusion of this tutorial, participants should be able to:

• implement practical planning

• recognize the principal regulatory requirements

• understand different approaches to eTMF design

• develop useful user requirements for an eTMF

• recognize the impact of an eTMF on trial-related processes

• evaluate potential IT solutions

Tutorial 2 09:00-17:00

eSUBMISSION – A HIGHLIGHT OF THE DIFFERENCES

Tutorial Co-Instructors:

Joris Kampmeijer, Head of Information Processing

Medicines Evaluation Board, The Netherlands

Hans van Bruggen, Senior Regulatory Affairs Consultant


This tutorial will provide a comprehensive overview on the considerations

for

electronic submissions within Europe, thereby focusing on the following:

• eCTD vs NEES

• NP vs. MRP vs. CP

• Initial MAA vs. Variations and other submission types

• Industry vs. Agency

• EU vs. US. vs. CA. vs. JP (and possibly CH and AU)

At the conclusion of this tutorial, participants should be able to:

• Decide whether to submit an eCTD or NEES in the EU depending on the

regulatory strategy for a product

• Manage eCTDs and NEES preparation and validation

• Manage eCTD lifecycle

• Understand the needs of both industry and agency

• Efficiently reuse documents and dossiers across multiple regions

08:30 Arrival & Registration

10:30 - 11:00 Coffee Break

12:30 - 14:00 Lunch Break

15:30 - 16:00 Coffee Break

2

11th Conference on European Electronic Document Management

Exhibiting CompaniesCompany Country

bioscience2 Belgium

CSC USA

DoubleBridge Technologies USA

Exalon GmbH Germany

EXTEDO Germany

fme AG Germany

Global Vision Inc. Canada

GxPi Ltd. UKLORENZ Life Sciences Group Germany

NextDocs USA

NNIT A/S Denmark

Phlexglobal Ltd. UK

Qumas Ireland

EXHIBITION

OPENING HOURS

Thursday, 2 December 2010

From 10:00 – 18:30

Networking reception:

from 17:30-18:30 in the exhibition hall

Friday, 3 December 2010

From 09:30 – 15:30

E X H I B I T I O N



09:00 Session 1 Level of Expertise: Intermediate

WELCOME AND INTRODUCTION

Melanie J. Clare, Center for Clinical Study Excellence, GlaxoSmithKline

Dimitri Stamatiadis, Project Director, Merck Serono, Switzerland

Keynote Speakers:

Data Management and Integration Strategies that Target Present Needs and Future Challenges

John P. Farrell, Principal Consultant, ISI (UK) Ltd., UK

Content Reuse: Vision versus reality

Morwenna Gould, Managing Director, Morphiris Ltd., UK

The Evolution of Submission Standards from the Perspectives of EMA, Industry and Vendor

Geoffrey Williams, Site-Head of Regulatory Operations, Roche Products Ltd., UK

3

THURSDAY | 2 DECEMBER 2010


VALIDATING THE INFORMATION ENVIRONMENT

Session Chairperson:


A lot of ink has flowed since the publication of 21 CFR part 11 on

electronic records and electronic signatures thirteen years ago, and

a lot of money too. In many cases for no good reasons as our

understanding of either topic was poor and our desire to quickly

solve them was big. Maturity came slowly through "hit and miss"

approaches but we have eventually gained a better understanding of

the nature, purpose and requirements of e-records management.

Join this session to learn how to efficiently validate EDMS and

submission systems and where e-signatures stand today.

Risk-based Validation, a practical experience

Frank Schalldach, Merck Serono, Switzerland

Rene Kasan, Subject Matter Expert, NNIT A/S, Switzerland

The Efficient Validation of EDM and Submission Management

Systems

Thomas Staedter, Extedo GmbH, Germany

e-records and e-signatures: thirteen years after (21CFRpart11)


11:00 Parallel-Session 2 Level of Expertise: Intermediate

eTMF IMPLEMENTATION


Karen Jane Redding, Business Development Director, Phlexglobal

Ltd., UK

The Outsourced Implementation of a Global eTMF

Jane Margaret Twitchen, Head of Project Management, Phlexglobal

Ltd., UK

Mark Hill, Global Head, Global Trial Master File Management, UCB,

USA

You Have Your eTMF Ready - Now what?

Martin Lillis, GCP Records Manager, Europe, Quintiles, UK

eCTD Meets eTMF

Murat Hamzakadi, Associate Regulatory Operations Director,

Astellas Pharma Europe R&D, The Netherlands

12:30 Lunch Break in the Exhibition Area

08:00 Registration and Welcome Coffee

10:30 Coffee Break in the Exhibition Area

THURSDAY | 2 DECEMBER 2010 PARALLEL SESSIONS

Unless otherwise disclosed, DIA acknowledges that the statements made by

speakers are their own opinion and not necessarily that of the organisation they represent, or that of the Drug Information Association.

Speakers and agenda are subject to change without notice.

Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA.

START OF CONFERENCE



4

17:30 End of Sessions

17:30 Reception in the Exhibition Area

18:30 End of Day 1

THURSDAY | 2 DECEMBER 2010 PARALLEL SESSIONS


eCTD


Hans van Bruggen, Senior Regulatory Affairs Consultant,


ASMF in eCTD



Implementation of eCTD Tuned Business Processes

Pierre Geruzet, Regulatory Operations Manager, GlaxoSmithKline

Biologicals, Belgium

Realising eCTD Capability with External Providers

Sibylle Teuchmann, Managing Director, Exalon GmbH, Germany


BUILDING A COMPLIANT TMF PROCESS


Eldin Rammell, Managing Director, Rammell Consulting Ltd., UK

The development of a TMF process that is compliant with global

regulatory and legal requirements takes a complete re-think of

principles that have typically been taken for granted by industry. A

process re-design project at Pfizer involved the introduction of several

radical concepts in terms of process and systems.

Redefining the Trial Master File

Ivan Walrath, TMF Process Owner, Pfizer, USA

The role of the DIA Reference Model in Defining TMF Content

Martin Thorley, Associate Director, Pfizer, UK

A Process-based Approach to Metadata Models

Eldin Rammell, Managing Director, Rammell Consulting Ltd, UK


OPERATING WITH SCIENTIFIC CONTENT


Melanie J. Clare, Center for Clinical Study Excellence,

GlaxoSmithKline

The Pharma industry’s current models of authoring and managing

documents can lead to multiple duplications of the same information,

across the long process of drug development, resulting in costly

implications for access, retrieval, consistency and updating. How do

we get closer to the utopia of creating information once and re-using

it many times? Is there a deep (enough) understanding by those

generating or consuming information, of the practical challenges to a

business in managing ‘content’ rather than ‘documents’?

What are the current experiences of companies attempting to do this?

Practical experiences will be shared at this session, with

representatives from industry, IT and vendors providing their

perspectives.

This session is currently in development. Please visit the DIA website

for updates.


eARCHIVING/RECORDS MANAGEMENT


Anita Paul, Head of Corporate Records Management, F. Hoffmann-

La Roche AG, Switzerland

Compliant eArchiving – Lessons Learnt

Michael Sojc, Corporate Information Governance & Management,

Subject Matter Expert, Novartis, Switzerland

"EDMS in The Cloud" - Opportunities and considerations for small

and mid-size pharma companies

Karsten Fogh Ho-Lanng, Chief Technology Officer, NNIT A/S,

Denmark

Successfully Applying Standards to Preserve Information Assets

Long-term

Uli Zipfel, Project Manager COREMAP, F. Hoffmann-La Roche AG,

Switzerland


The DIA Document and Records Management (DRM) SIAC provides a discipline-specific, global community where members can share common experiences

and knowledge and connect with others in their particular field.

DIA Document and Records Management (DRM) SIACCo-Chairpersons: Mr. James Averback and Mr. Graham E Shelvey

Mission

The new Document and Records Management (DRM) SIAC will focus on the following areas: document management best practices, emerging technology and

concepts, architecture, workflow, records retention, multi-purposing of information and document repositories, as well as information sharing and collaboration.

To join this SIAC please contact Sarah [email protected]

EDM Reference Model

The EDM Reference Model is a document management initiative aimed at developing a taxonomy/metadata reference model that can ultimately be shared by

biopharmaceutical organisations as a common starting point for building sustainable, shareable EDM repositories.

The DIA Reference Models will be discussed in Session 5.




DIA REFERENCE MODELS


Steve Scribner, Principal Consultant, International Life Science

Solutions, Inc., USA

Update on the EDM Reference Model Programme

Steve Scribner, Principal Consultant, International Life Science

Solutions, Inc., USA

TMF Reference Model, extension to the EDM Reference Model

Lisa Mulcahy, Consultant - Pharmaceutical Research, Mulcahy

Consulting, LLC, USA

eDMS Implementation Project and Reference Model aspects at

Bayer Schering Pharma

Wolfgang Schulz, Special Project Advisor, GRA Global Compliance

and Operations, Bayer Shering Pharma AG, Germany


EMERGING MARKET SESSION


Joris Kampmeijer, Head of Information Processing, Medicines

Evaluation Board, The Netherlands

The CTD, eCTD and ACTD in Southeast

Harv Martens, Vice President of Operations for North America and

Japan, Extedo Inc., USA

Overcoming EDM Challenges when Repurposing EU and US

Submission Documentation for Use in the Latin American RegionMichelle A. Perez, Manager, Regulatory, Consulting/Professional

Services, Image Solutions, Inc. (ISI), USA

Regulatory Challenges from CIS to South East Europe in the Light

of Electronic Submissions

Cedo Jakovljevic, President and CEO, Infotehna Group, Slovenia


DOCUMENT AND SUBMISSION MANAGEMENT

Thomas Altenwerth, Global Submission Management and

Archiving, Bayer Schering Pharma, Germany

The maintenance of submission documentation along the lifecycle

of your products needs to address multiple targets.

A well understood process with standardised and applied meta data

is essential for efficient organising and exchange of this information.

Hear how to manage the flow of documents - within and beyond

your company.

eDMS/eCTD in a Generic Pharmaceutical Company

Tom Manussen, Director Regulatory Affairs, Disphar International

BV, The Netherlands

More Than Just an Envelope: RPS progress report

Joel Finkle, Director, Regulatory Informatics, Image Solutions, Inc.

(ISI), USA

Business Process Management and Master Data Management

Erick Jacques Gaussens, Chief Scientific Officer, ProductLife Group,

France

Francois Versini, Organisation, Systèmes de Management, Qualité,

Processus, Logistique, Ressources Humaines, i3L integration

triLogique, France

15:30 Session 8

AGENCY/REGULATORY SESSION




France

Miguel Bley, MIRE, Responsable des relations européennes, Head

of European Affairs, AFSSAAPS, France

USA

Gary Gensinger, Deputy Director, Office of Business Process

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

UK / EU

Claudia Galeazzo, Product and Application, Business Support,

European Medicines Agency, EU

Canada

Vianney Caron, E-Review Project Lead, Therapeutic Products

Directorate, Health Canada, Canada

FRIDAY | 3 DECEMBER 2010

08:00 Welcome Coffee in the Exhibition Area


12:00 Lunch Break in the Exhibition Area


16:30 End of Conference

5

HOTEL INFORMATION

The DIA has blocked a number ofrooms at the:

Hotel Le Meridien Nice - France1, Promenade des Anglais06046 Nice - FrancePhone: +33 4 97 03 44 44Fax: +33 4 97 03 44 45

Special rate:

EUR 135.00 per classic standard single room inclusive breakfast, tax,

services, VAT plus tourist tax of EUR 1.20 per day.

To make your reservation:

http://www.starwoodmeeting.com/Book/11thDIA

Important: Please complete your reservations 30 November 2010.

Cancellation Policy:

Cancellation of the hotel booking must be in writing directly to the hotel.

Your reservation can be cancelled until 8 days prior arrival date with no

penalty. All no shows will be billed for the entire stay.

ASK THE REGULATORS!

A panel of Agency/Regulatory representatives will be available to answer

questions and share dialogue. This is a unique opportunity to learn about the

latest Regulatory initiatives and to obtain current and practical advice from

key agency personnel.

If you have specific questions that you would like to ask the panellists

regarding regulatory submissions standards, processes, regulations,

guidance, or initiatives, please send them to [email protected]

(Subject: Questions for the Agency/Regulatory Session) no later than 18

November 2010.

Please note that not all questions may be answered due to the time

limitations.



Register for

upcoming DIA

events in Europe

1st Joint DIA/EMA Workshop on Statistical

Methodology in Clinical R&D

27-29 September 2010 | Vienna, Austria

Joint EFGCP Children’s Medicines Working Party 6th

Annual Conference and

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Current and Future Medical Child Care: Visions, Daily

Challenges, Ways Forward

28-29 September 2010 | London, UK

Joint DIA/EFGCP Pharmacovigilance Audit and

Inspection Workshop - Opportunities for Patient

Safety

1 October 2010 | London, UK

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DIA Members: Register by 10 September and save €200!

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Building a new system to get effective treatment to

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DIA Members: Register by 23 September and save €100!

Special Discount

The 2nd DIA Health Technology Assessment Conference is immediately following the DIA Future Direction for Orphan Drugs in Europe Conference

on 3 November. The first half day of the HTA Conference continue the

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Combination Products – Finding the Right Regulatory

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9 November 2010 | Zurich, Switzerland

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23 November 2010 | London, UK

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26 November 2010 | London, UK

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Forum: Is the EU Regulatory Framework Ready?

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DIA Members: Register by 15 October and save €200!

11th Conference and Exhibition on European Electronic

Document Management -

The New Frontiers

1-3 December 2010 | Nice, France

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9th Middle East Regulatory Conference MERC 2011

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March 2011 | London, UK

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DIA Members: Register by 28 January and save €150!

For more information and a complete listing of all

DIA conferences, please visit www.diahome.org >click on Conferences / Meetings

Call the DIA in Europe on +41 61 225 51 51 or email:[email protected]



CANCELLATION POLICY All cancellations must be in writing and received at the DIA office by 17:00 CET on 23 November, 2010

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and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registrants.

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10110DIA

REGISTRATION FORM ID# 1011011th Conference on European Electronic Document Management - The New Frontiers

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