Drug Information Association Logo
Corporate Tagline

14th DIA Conference on European Electronic Document Management

Nov 21 2013 8:30AM - Nov 22 2013 5:00PM | DoubleTree by Hilton (formerly The Burlington Hotel) Upper Leeson Street Dublin 4 IRELAND

« Back to Listing

Overview 

Mobile App now available!

Free EDM Mobile App is now available on iPhone, Android, and mobile web. Search for DIA EDM2013 in your app store and download the free app.

Here's How to Get Your App for Android devices:
Go to the Android Market on your device and search for DIA EDM2013 to locate the app and install.
Or use the direct link to the Android version

Here's How to Get Your App for Apple devices:
Go to the Apple App Store on your device and search for DIA EDM2013 to locate the app and install.
Or use the direct link to the Apple version

Mobile Web
If you want to access the app through a traditional device, please use the Mobile Web Version

Log in with the email address you submitted when registering.

iPhone users turn Settings > Mail/Contacts/Calendar > Calendars section >Time Zone Support ON or else reminders and notifications will use Eastern Standard Time (GMT -5).


During the middle-ages alchemists were looking for the Philosopher’s Stone. As it was believed then, the mythical substance could not only turn lead into gold, but also prolong life and restore youth by rejuvenation. Although the goal set was not achieved, alchemy paved the way to scientific method and so to the medical advances of today. This has transformed our lives in more ways than one.

Computer use and the introduction of digital technologies has affected virtually every aspect of daily life in the last decades of the 20th century. One might think that the bulk of the digital revolution was over. Is computer science getting old? Surprisingly, as the 21st century advances, we are witnessing an even greater acceleration of technology with tablets, social media, the cloud and unprecedented computing power at hand.

Enabling technologies, including changing taxonomy, are undergoing what humans always dreamed for themselves: A second youth, a rejuvenation.

Join us at the 14th European DIA eDM Conference to find out the latest trends in document management, content and information management, electronic submissions and a lot more… and witness the rejuvenation of eDM.

Failté Ireland      Failté Ireland

Register for the EDM and for the Joint DIA/IMB Common European Submissions Platform (CESP) Information Day and receive a 25% discount on the CESP registration rate. Contact us for details.

Who Should 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

Hotel & Travel 

DIA has blocked a number of rooms at the following hotel:

The DoubleTree by Hilton (former "The Burlington Hotel")
Upper Leeson Street
Dublin 4, Ireland
Tel: +353 (0)1 618 5600
Fax: +353 (0)1 6185693

In order to book your accommodation, we would kindly ask you to click here, and fill out the Hotel Booking Form.

Kindly click here to access the Hotel website

Contact Information 

For registration information please call Customer Services on +41 61 225 51 51

For programme information please contact Sharon Evans Schuler at DIA: sharon.evans@diaeurope.org

For information on Exhibition please contact Roxann Schumacher at DIA: roxann.schumacher@diaeurope.org

 

Program Committee 

Previous Next

Agenda  

Tutorials Wednesday, November 20, 2013

  • 9:00AM - 5:00PM

    Room: Meeting Room 8

    Tutorial 01: IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP)
    Many national and international groups are developing standards for controlled vocabularies to identify medicinal products, substances and medical devices, including IDMP. Applying these standards to obtain a consistent and transparent medicinal product database internally will be a laborious and challenging task. Having experienced the difficulties with XEVMPD showed the need for companies to get ready for ISO IDMP well in advance of the implementation date. This tutorial provides attendees with a business case of establishing a controlled vocabulary, to be used as single source of truth in the various stages of a product lifecycle. This vocabulary will support all relevant disciplines and all types of exchange of information concerning the product’s quality, safety and efficacy. As a bonus the company will be ready to comply with ISO IDMP.
  • 9:00AM - 5:00PM

    Room: Meeting Room 2

    Tutorial 02: ELECTRONIC TRIAL MASTER FILE (eTMF) – MOVING FROM IMPLEMENTATION TO PROJECT EXCELLENCE
    Technology solutions for managing electronic Trial Master File (eTMF) documents are now established in many sponsor and contract research organisations. However, organisations experience many challenges as they begin to implement solutions, sometimes several years later! This tutorial will provide attendees with an opportunity to discuss some of the more challenging aspects of eTMF implementation. Through instructor-facilitated discussions, guidance will be provided in a wide range of relevant topics.

Day 1 Thursday, November 21, 2013

  • 9:00AM - 10:30AM

    WELCOME AND INTRODUCTION


    Session Chair(s):

    • Dimitri Stamatiadis, PhD,MBA
      Founder and CEO
      MAIA Consulting SARL, Switzerland
    • Hans van Bruggen, MSc
      Senior Regulatory Affairs Scientist
      eCTDconsultancy B.V., Netherlands

    Rejuvenation is about change, renewal, reinventing.Changing our way of working with each other, among industrial competitors, sponsors and regulators, developers and investigators. Renewing the way we use technology, old and new, to unleash our intellectual potential. Reinventing the way we struggle to bring medicines to patients, relief to suffering and ultimately accomplishment for our own selves.

    Speaker(s):

    • Technology- Regulatory Friend or Foe?
      Suzanne McDonald
      Director-IT and Change Management
      Irish Medicines Board, Ireland
    • The Activities and Vision of TransCelerate
      David Evans, MS
      Managing Director
      Accenture, United States
  • 11:00AM - 12:30PM

    ELECTRONIC TRIAL MASTER FILE (eTMF) INSPECTION


    Session Chair(s):

    • Bram Van Den Brink
      Senior Manager PMO, EPD-IT
      Abbott Healtcare Products B.V., Netherlands

    Regulatory Inspections are viewed as the greatest challenge of any eTMF process and system. The MHRA and EMA have clearly stated their requirements from an eTMF system, especially regarding: • need for direct access • minimal training • chain of custody • effective organisation and structure • timelines for submission • single source • minimising signatures • validated process This session will focus on case studies and real experiences with Regulatory Inspections and eTMFs.

    Speaker(s):

    • Considerations for Providing DIRECT Access to the eTMF (and other content repositories) for Health Authority Inspections
      Lisa D. Mulcahy
      Owner and Principal Consultant
      Mulcahy Consulting LLC, United States
    • Managing an eTMF for Inspection Readiness
      Martin David Thorley
      Associate Director - Information and Records Manager
      Pfizer Ltd, United Kingdom
    • What to Expect During an MHRA eTMF Inspection – experience, challenges and best practices based on a recent inspection
      Wendy Trimboli
      Eisai Inc, United States
  • 11:00AM - 12:30PM

    eINFRASTRUCTURE FOR TESTING, INTEGRATION AND CONFIGURATION OF SOFTWARE (ETICS)


    Session Chair(s):

    • Harv W Martens
      President
      ING America Inc, United States

    After 11 years in the public domain, the eCTD standard: • Is more stable • Is better understood by industry, regulators and vendors • Is more widely implemented in ICH and non-ICH countries • Has mature tools available However, anyone who has tried to migrate submissions from one eCTD publishing tool to another, or has submitted eCTDs to multiple regulatory agencies, will likely agree that issues of compliance and interoperability between tools remain. The ETICS study, now in its third iteration and a special project of the IRISS Forum, was designed to explore these issues and to guide vendors toward a better understanding of ICH and agency requirements as well as demonstrate how their tools interoperate with competitors’ tools. This session will review the findings of ETICS III in the US, EU and Canada.

    Speaker(s):

    • Panel
      Bryan Ennis
      Director, R&D Customer Success
      Veeva Systems, United States
    • Panel
      Ted Hanebach, RAC
      Director, Regulatory Operations
      Optum, Canada
    • Panel
      John-Paul Smith
      Regulatory Operations
      Astellas Pharma B.V., Netherlands
  • 2:00PM - 3:30PM

    ELECTRONIC TRIAL MASTER FILE (eTMF) LEVERAGING


    Session Chair(s):

    • Karen Redding, MPharm
      Global Business Development Director
      Phlexglobal Ltd, United Kingdom

    A TMF is not just a collection of documents, it is a powerful knowledge base – within a study or across a portfolio of studies. If properly managed and harnessed, the TMF can be of strategic use in terms of lessons learned and historical activities and can provide a basis for future decision making. On a study basis, using design parameters, milestones and events can be used to understand how complete a TMF is. Clinical data warehousing can also be leveraged to create a more holistic eTMF. This session will investigate the business intelligence that can be gained from a TMF, and specifically an eTMF.

    Speaker(s):

    • TMF as a Knowledge Management Catalyst
      Rohin Rajan
      Management Consultant - Life Sciences Strategy
      Deloitte Consulting, United States
    • TMF as a Knowledge Management Catalyst
      Keith D. Davis, MBA
      Global Director & Head, R&D Records Management
      Biogen Idec, United States
    • 21st Century TMF -Insights and Trends
      Paul Fenton, MBA,MS
      President & CEO
      Montrium, Canada
    • Panel Discussion
      Lisa D. Mulcahy
      Owner and Principal Consultant
      Mulcahy Consulting LLC, United States
    • Panel Discussion
      Michael M. Sauter
      Senior Director, Regulatory Operations
      Biogen Idec, United States
    • Panel Discussion
      Martin David Thorley
      Associate Director - Information and Records Manager
      Pfizer Ltd, United Kingdom
  • 2:00PM - 3:30PM

    INTEGRATION, CONSOLIDATION AND INTERFACING


    Session Chair(s):

    • Dimitri Stamatiadis, PhD,MBA
      Founder and CEO
      MAIA Consulting SARL, Switzerland

    Join this session to learn how integration of different technologies can multiply their value. Rejuvenation may be achieved by mixing ingredients wisely.

    Speaker(s):

    • Clinical Architecture: Innovations in Trial Processes & Systems
      Christopher McSpiritt
      Principal Consultant
      Paragon Solutions, United States
    • "Smarter" Information Management
      Michael Rosenblatt
      Global Head, Regulatory Technology Solutions
      Genentech, United States
    • How eCTD 4.0 Will Improve the Reusability of Regulatory Information
      Gerhard Neurauter
      EXTEDO GmbH, Germany
  • 4:00PM - 5:30PM

    DESTRUCTION AND RETENTION AT CLINICAL SITES


    Session Chair(s):

    • Betsy Fallen, RN
      Site Ready Lead, Global Clinical Trial Operations
      Merck & Co., Inc, United States

    As the pharmaceutical industry moves to a primarily digital environment, most clinical sites are left with file cabinets, boxes and perhaps rooms of paper generated for past trials. It is understood that the documents are controlled by the site, but who owns the retention decision and financially supports it has long been a question with different interpretations. The decision to retain the paper can have both a regulatory and legal ingredients with a perhaps dash of reluctance added for interest. We will present a case study from one sponsor company who has adopted a global process to provide answers to the sites burdened with paper as part of the overall look at site based documentation.

    Speaker(s):

    • Essential Documents at the Clinical Site: Please retain until we say STOP
      Betsy Fallen, RN
      Site Ready Lead, Global Clinical Trial Operations
      Merck & Co., Inc, United States
    • Site View of SDR
      Lisa D. Mulcahy
      Owner and Principal Consultant
      Mulcahy Consulting LLC, United States
    • Site View of SDR
      Ashley Smith
      Project Manager, Life Sciences
      TransPerfect Translations, United States
  • 4:00PM - 5:30PM

    eSUBMISSION


    Session Chair(s):

    • Hans van Bruggen, MSc
      Senior Regulatory Affairs Scientist
      eCTDconsultancy B.V., Netherlands

    Whereas eSubmission relates to submission teams within a pharmaceutical industry, it actually impacts all contributors to regulatory dossiers. It goes beyond format; such as indexing of dossiers, applicants, products, submissions and documents. Properly and consistently defined metadata definitions offer contributors to retrieve information from an electronic repository. Subsequently, information can be shown in context of a particular product in a particular country or in any other context. One might view the content; another might view a dashboard of what was submitted where and others might use the same information to analyse differences across dossiers. This session teaches us on where we are concerning eSubmission in Switzerland; where we might improve consistency and taxonomy in general and what to expect from eCTD v4.0.

    Speaker(s):

    • A Decade of eCTD- time to rejuvenate
      Michiel Stam
      Manager, Regulatory Operations
      Qdossier B.V., Netherlands
    • RPS/eCTD v4.0 topic
      Joerg Schnitzler, PharmD,MSc,RPh
      Head of Global Regulatory Operations
      Boehringer Ingelheim Pharma GmbH & Co KG, Germany
    • Swissmedic Update
      Janine Weix
      Scientific Collaborator, Department Submissions
      Swissmedic, Switzerland

Day 2 Friday, November 22, 2013

  • 8:00AM - 9:30AM

    THE CLOUD


    Session Chair(s):

    • Paul Fenton, MBA,MS
      President & CEO
      Montrium, Canada

    Cloud computing has been around for many years and the use of cloud-based solutions in professional environments has recently reached unprecedented dimensions. However, regulated industries such as pharma and biotech have been hesitant to adopt the cloud in spite of its obvious advantages both in terms of functionality and cost. Validation has been a concern as it is pushed even further away from companies' direct control and the use of cloud-based solutions to collaborate and ultimately to submit registration dossiers for new drugs needs to be understood and mastered by the relevant experts. Join this session to hear about the genuine rejuvenation of our ways of working: The Cloud.

    Speaker(s):

    • GAMP 5 in more detail for Validation of an Electronic Document Management Systems “in the Cloud” (Part II)
      Keith Williams, MSc
      Founder and Chief Executive Officer
      GXPi, United Kingdom
    • GAMP 5 in more detail for Validation of an Electronic Document Management Systems “in the Cloud” (Part II)
      Stephen Long
      Computer Systems Compliance and Quality
      GXPi, United Kingdom
    • Around the World in Many Ways: Managing Local Affiliates
      Kate Wilber
      Director, Product Management - Vault Europe
      Veeva Systems, United Kingdom
    • Compliant Cloud Based eCTD Management – Risk or chance?
      Rainer Schwarz
      General Manager & Sales Director, Europe
      Cunesoft GmbH, Germany
  • 10:00AM - 11:30AM

    eHEALTH


    Session Chair(s):

    • Erik Vollebregt, LLM
      Partner
      AXON Lawyers, Netherlands

    Electronic document management for the purpose of provision of eHealth and mHealth services is becoming more and more important for companies in the healthcare sector. While the possibilities seem endless, companies often overlook the current and near-future regulatory controls on the collection, processing, anonymising, repurposing and export of personal health data. This session will discuss how to implement compliant eHealth and mHealth strategies in the EU and how to plan for the current EU regulatory development in regulation of personal health data.

    Speaker(s):

    • Developments in EU Regulatory Requirements Regarding Personal Health Data
      Erik Vollebregt, LLM
      Partner
      AXON Lawyers, Netherlands
    • eDM and mHealth Strategies for Pharmaceutical Companies
      Erik Siemens
      Channel Lead
      AstraZeneca, Belgium
  • 10:00AM - 11:30AM

    DIGITAL PRESERVATION


    Session Chair(s):

    • Bram Van Den Brink
      Senior Manager PMO, EPD-IT
      Abbott Healtcare Products B.V., Netherlands

    Digital preservation is to maintain the ability to display, retrieve, and use digital information in the face of quickly changing technological and organisational infrastructures, join this session to get better understanding how to approach storage of digital information.

    Speaker(s):

    • Understanding Requirements for Electronic Archiving
      Eldin Rammell
      Managing Director & Principal Consultant
      Rammell Consulting Ltd, United Kingdom
    • A Risk-Based Approach to Long-Term Retention and Access of Electronic Documents and Records
      Matthew Addis, PhD
      CTO
      Arkivum Ltd, United Kingdom
    • Preserving Evidential Weight for Digital Documents
      Russell Joyce
      Director & Principal Consultant
      Heath Barrowcliff Consulting Ltd, United Kingdom
  • 1:00PM - 2:30PM

    COLLABORATION, INCLUDING CROs AND OTHER THIRD PARTIES


    Session Chair(s):

    • Dimitri Stamatiadis, PhD,MBA
      Founder and CEO
      MAIA Consulting SARL, Switzerland

    Setting up and using today’s eDM systems is not a simple task even within the borders of our own companies. Let alone when they are created, hosted and managed by someone else. Still this mode of operation holds great promises and progresses every day. So let’s learn how to master collaboration and harvest great benefits.

    Speaker(s):

    • Validation and Implementation of Externally Owned Systems
      Laura Josephine Barrett
      Publishing Site Manager
      GlaxoSmithKline, United Kingdom
    • Using a Document Collaboration Maturity Model to Enhance the Writing and Review of Medical Documents
      Dave Sheppard
      Business Development Manager
      PleaseTech Ltd, United Kingdom
    • ICON and the eTMF: Supporting a Diverse Client Population with Big Data
      Troy Deck
      CEO
      Wingspan Technology, United States
    • ICON and the eTMF: Supporting a Diverse Client Population with Big Data
      John Blunden
      Program Manager
      ICON Plc, Ireland
  • 1:00PM - 2:30PM

    EXTENDED EUDRAVIGILANCE MEDICINAL PRODUCT DICTIONARY (XEVMPD)/ IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP)


    Session Chair(s):

    • Andrew P. Marr, PhD
      Managing Director
      Marr Consultancy Ltd, United Kingdom

    XEVMPD has been implemented for more than one year but data validation and maintenance are yet to start. Significant quality issues exist with data already submitted. Meanwhile IDMP implementation is still scheduled for July 2016. This session will address the current status, the plans for 2014 and beyond, and the challenges that they will bring.

    Speaker(s):

    • Medical Product Dictionaries and Information Management Processes
      Joel Finkle
      Senior Strategist, Regulatory Informatics
      CSC Life Sciences, United States
    • Current Status of XEVMPD and Plans for 2014
      John W. Kiser, MSc
      Senior Director, Regulatory Operations
      Abbvie Ltd., United States
    • Managing the Transition – XEVMPD to ISO IDMP
      Fiona Maini, MS
      Senior Manager, Management Consulting
      Deloitte Ltd, United Kingdom
  • 3:00PM - 4:00PM

    MEET THE REGULATORS


    Session Chair(s):

    • Andrew P. Marr, PhD
      Managing Director
      Marr Consultancy Ltd, United Kingdom
    • Hans van Bruggen, MSc
      Senior Regulatory Affairs Scientist
      eCTDconsultancy B.V., Netherlands

    The session will provide a forum for attendees to address questions directly to regulators about topics and issues of concern to them. These may have arisen during other sessions of the conference or be items that have not be raised at all.

    Speaker(s):

    • Panel
      Suzanne McDonald
      Director-IT and Change Management
      Irish Medicines Board, Ireland
    • Panel
      Gary M. Gensinger, MBA
      Deputy Director, Office of Business Informatics, CDER
      FDA, United States
    • Panel
      Janine Weix
      Scientific Collaborator, Department Submissions
      Swissmedic, Switzerland

Exhibits  

.
  • Accenture Life Sciences
  • Arkivum Limited
  • Cunesoft GmbH
  • EMC Corporation
  • Ennov
  • EXTEDO GmbH
  • fme AG
  • Formpipe
  • GXP Limited
  • LIQUENT, A PAREXEL Company
  • LORENZ Life Sciences Group
  • Mission3
  • Montirum
  • NextDocs
  • Paragon Solutions
  • Phlexglobal Ltd
  • QUMAS
  • Syntel Europe Ltd
  • Veeva Systems
  • Wingspan Technology

Registration Fees 

Other Fees

Student
€150.00

Member

Member Academia
€683.00
Member Government
€683.00
Member Standard
€1365.00
One Day Rate
€410.00
One Day Rate
€819.00
One Day Rate
€410.00

Non-Member

NonMember Academia
€798.00
NonMember Government
€798.00
NonMember Standard
€1480.00
One Day Rate
€525.00
One Day Rate
€525.00
One Day Rate
€934.00
Registration Fees for Additional Offerings
Tutorial 01: IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP) - Industry Rate
€550.00
Tutorial 02: ELECTRONIC TRIAL MASTER FILE (eTMF) – MOVING FROM IMPLEMENTATION TO PROJECT EXCELLENCE - Industry Rate
€550.00
Register Online
« Back to Listing Back To Top