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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
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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
eCTDconsultancy, The Netherlands
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
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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
11:00 Session 2 Level of Expertise: Intermediate
VALIDATING THE INFORMATION ENVIRONMENT
Session Chairperson:
Dimitri Stamatiadis, Project Director, Merck Serono, Switzerland
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)
Dimitri Stamatiadis, Project Director, Merck Serono, Switzerland
11:00 Parallel-Session 2 Level of Expertise: Intermediate
eTMF IMPLEMENTATION
Session Chairperson:
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
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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
14:00 Session 3 Level of Expertise: Intermediate
eCTD
Session Chairperson:
Hans van Bruggen, Senior Regulatory Affairs Consultant,
eCTDconsultancy, The Netherlands
ASMF in eCTD
Hans van Bruggen, Senior Regulatory Affairs Consultant,
eCTDconsultancy, The Netherlands
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
14:00 Parallel-Session 3 Level of Expertise: Intermediate
BUILDING A COMPLIANT TMF PROCESS
Session Chairperson:
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
16:00 Session 4 Level of Expertise: Intermediate
OPERATING WITH SCIENTIFIC CONTENT
Session Chairperson:
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.
16:00 Parallel-Session 4 Level of Expertise: Intermediate
eARCHIVING/RECORDS MANAGEMENT
Session Chairperson:
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
15:30 Coffee Break in the Exhibition Area
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.
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08:30 Session 5 Level of Expertise: Intermediate
DIA REFERENCE MODELS
Session Chairperson:
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
10:30 Session 6 Level of Expertise: Intermediate
EMERGING MARKET SESSION
Session Chairperson:
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
13:30 Session 7 Level of Expertise: Intermediate
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
Session Chairperson:
Hans van Bruggen, Senior Regulatory Affairs Consultant,
eCTDconsultancy, The Netherlands
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
10:00 Coffee Break in the Exhibition Area
12:00 Lunch Break in the Exhibition Area
15:00 Coffee 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.
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