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15th Annual Conference on Electronic Document Management (eDM)

Dec 2 2014 7:30AM - Dec 3 2014 4:00PM | Maritim Hotel Berlin Stauffenbergstrasse 26 10785 Berlin Germany

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Overview 

Enhance your meeting experience. Full-day tutorials offered on Monday, 01 December. Register now! 

Tutorial 1

Electronic Master Files (eTMF) - moving from implementation to project excellence 

Tutorial 2 

Understanding the Impact of Identification of Medicinal Products (IDMP) on Processes, Data Provision, Governance and IT Architecture

See details further below. 

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Meeting Overview 

Standardisation is key to the success of adoption of new techniques and processes. If houses were not wired with copper wires providing power of a standard voltage through a predefined power outlet, Edison would not have been famous for his successful introduction of light bulbs. However, national or regional standards have been developed for power outlets and voltage but nobody is trying to get the responsible parties together to globally harmonise the voltage and power outlets. These kind of obvious standards have become a commodity and when travelling abroad, everybody uses adaptors that make the connection between regional power outlets and voltages. 

How come that in the age of modern technology and quick communication we are still aiming at global standards? Should we be less dogmatic about global standards? Should we focus more on adaptors? Or electronic and automated adaptors that allow transfer of information from sender to recipient and vice versa? This is not limited to industry-to-agency transfer, but is also applicable to transfers between CROs and sponsor and between various applications within a company, such as, but not limited to, SAP, eDMS, eTMF, eSubmission, RIM, LIMS, SPL, electronic health records, electronic data capture and electronic forms.  

Come and learn about the benefits and constraints associated with the various topic-related processes and contribute to answering the question whether standardisation is a blessing or a curse.

 

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 

A limited number of rooms are available a special rate at the event hotel:
Maritim Hotel Berlin
Address: Stauffenbergstrasse 26, 10785 Berlin, Germany
Tel:  +49 (0) 30 2065-0
Web: http://www.maritim.com/en/hotels/germany/hotel-berlin

Single room EUR 139.00 incl. breakfast and VAT
Double room EUR 179.00 incl. breakfast and VAT
Please note those guests travelling on business are exempt from additional Berlin city council tax of 5 %.

To make your reservation please click here

Attendees should make reservations as soon as possible using the promotional code DIA14110. DIA rate is guaranteed until 1 November 2014, or until room block is filled. After this rooms are subject to availability and prices may vary.

Contact Information 

For registration information please call Contact Center 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

DIA Europe
Kuechengasse 16
4051 Basel
SWITZERLAND

TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: diaeurope@diaeurope.org

Program Committee 

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Agenda  

Tutorials Monday, Dec 01, 2014

  • 9:00AM - 5:00PM (Central Europe Standard Time)

    01 - ELECTRONIC TRIAL MASTER FILES (eTMF) - MOVING FROM IMPLEMENTATION TO PROJECT EXCELLENCE

    Technology solutions for managing electronic Trial Master File (eTMF) documents are now established in many sponsors and contract research organisations. However, companies often experience 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.

  • 9:00AM - 5:00PM (Central Europe Standard Time)

    02 - UNDERSTANDING THE IMPACT OF IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP) ON PROCESSES, DATA PROVISION, GOVERNANCE AND IT ARCHITECTURE

    The tutorial will give insight in the following areas:

    • Background of the IDMP standards and legislation
    • Structure and contents of the IDMP standards
    • Typical data mapping activities and results
    • IT architecture and application consequences
    • Specific areas of attention include clinical particulars and reporting of consistency of product information        

Day 1 Tuesday, Dec 02, 2014

  • 7:30AM - 8:30AM (Central Europe Standard Time)

    REGISTRATION AND WELCOME COFFEE
  • 8:30AM - 10:00AM (Central Europe Standard Time)

    WELCOME AND INTRODUCTION: STANDARDISATON, WHERE ARE WE?


    Session Chair(s):

    • Eldin Rammell
      Managing Director & Principal Consultant
      Rammell Consulting Ltd, United Kingdom

    Standardisation is becoming one of the most critical topics as our industry seeks to reduce costs, encourage harmonisation and improve efficiency. Our keynote speakers will bring us up-to-date with some key developments in this space for electronic document management and challenge our thinking right at the outset of our conference. Our speakers will cover standardisation developments for trial master files, regulatory submissions, IDMP and telematics, to name but a few!

    Speaker(s):

    • Document Management Technologies - what does the future hold?
      Jonathan Burd
      Solution Director
      GXPi, United Kingdom
    • EU Telematics Strategy
      Thomas Balzer
      BfArM, Germany
    • ISO, the IDMP Standards and Their Impact in the Community
      Christian Hay
      GS1 Global Office, Belgium
  • 10:00AM - 10:30AM (Central Europe Standard Time)

    COFFEE BREAK IN THE EXHIBITION AREA
  • 10:30AM - 12:00PM (Central Europe Standard Time)

    HOW BUSINESS CONTRIBUTES TO PROCESS VALIDATION/INTEGRATION


    Session Chair(s):

    • Hans van Bruggen, MSc
      Director and Senior Regulatory Affairs Consultant
      eCTDconsultancy and Qdossier, Netherlands

    Over the past 30 years we have shifted from information management on paper to digital information management using computers. However, until now, many processes are still based on paper thinking. Often we do not fully trust the automated processes, even though the systems have proven to do jobs as intended. People still tend to exchange information through e-mail, work outside validated systems and try to apply shortcuts in electronic processes. This session will explain more about why systems should be perceived as reliable, how data can be considered authentic and how to achieve that true perception by the users.

    Speaker(s):

    • How Many Eggs Make Six?
      Russell Joyce
      Director & Principal Consultant
      Heath Barrowcliff Consulting Ltd, United Kingdom
    • Transforming Regulatory – Creating an Active Submissions Archive with Integrated Regulatory Correspondence
      Steve Scribner
      Principal Consultant - Life Sciences
      EMC, United States
    • Implementing an eDMS and eSubmission Tool in Two Months
      Karmen Umek Luzar
      Consultant & Project Manager
      INFOTEHNA, Slovenia
  • 12:00PM - 1:30PM (Central Europe Standard Time)

    LUNCH IN THE EXHIBITION AREA
  • 1:30PM - 3:00PM (Central Europe Standard Time)

    PHARMACOVIGILANCE LIFECYCLE MANAGEMENT FROM CLINICAL TESTING TO POST-MARKETING SURVEILLANCE – ELEMENTS, PERMANENT AND AD HOC REQUIREMENTS, AND THE POSSIBILITY TO MANAGE THEM ELECTRONICALLY


    Session Chair(s):

    • Markus Dehnhardt, PhD
      Pharmacovigilance Officer
      Kohne Pharma GmbH, Germany

    The session will focus on a review of the electronic document management for regulated documents of the Trial Master File (TMF), the Pharmacovigilance System Masterfile (PSMF), and during Pharmacovigilance lifecycle management. We will identify the individual documents required, their structure and content, and try to highlight the possibilities for automated information management.

    Speaker(s):

    • Moving from an On-Premise to a Cloud-Based eDMS for Regulated Documents and eTMF - Part 1
      Mathias Ganz
      Director Development & Reg. Informatics
      IPSEN, France
    • Moving from an On-Premise to a Cloud-Based eDMS for Regulated Documents and eTMF- Part 2
      Benoit Poupin
      Director IT Regulatory and CMO
      Ipsen, France
    • Managing the Intersections between Regulatory and Pharmacovigilance
      Mohamed Adib
      Senior Director Global Reg. Affairs
      Gruenethal GmbH, Germany
  • 1:30PM - 3:00PM (Central Europe Standard Time)

    eREGULATORY CHALLENGES


    Session Chair(s):

    • Joerg Schnitzler, PharmD, MSc, RPh
      Head of Global Regulatory Operations
      Boehringer Ingelheim Pharma GmbH & Co KG, Germany

    Several new standards for the transmission of structured regulatory information are being implemented over the course of the next two to four years. While the deadline for EVMPD is approaching fast, the preparation for IDMP is starting in parallel. And ten years after the introduction of the eCTD standard the development of the Next Major Version v4.0 is reaching ICH Step 2 and opens now for public consultation. All these new requirements will require flexible and scalable technical solutions to handle the transition from existing standards.

    Speaker(s):

    • Learnings from XEVMPD to Take Forward in IDMP
      Jasper Riksen
      Regulatory Operations Associate
      Astellas Pharma Europe BV, Netherlands
    • Cloud-based Management of eCTD Global Submission Planners
      Mauricha F. Marcussen, MBA
      Chief Executive Officer
      Auditgraph, United States
    • RPS and eCTD v.4.0
      Joerg Schnitzler, PharmD, MSc, RPh
      Head of Global Regulatory Operations
      Boehringer Ingelheim Pharma GmbH & Co KG, Germany
  • 3:00PM - 3:30PM (Central Europe Standard Time)

    COFFEE BREAK IN THE EXHIBITION AREA
  • 3:30PM - 5:00PM (Central Europe Standard Time)

    eTMF Challenges


    Session Chair(s):

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

    An electronic Trial Master File (eTMF) is not just a piece of technology, it is all about getting efficient and effective processes and workflows in place to ensure that the eTMF is contemporaneous and ready for inspection at any time. This session will take you through implementation, through dealing with CROs and ending up focussing on inspections.

    Speaker(s):

    • eTMF Standardisation from a CRO Perspective
      Jamie Marie Toth
      Director, Business Process & Solutions - eTMF, Clinical Development Services
      Covance Inc., United States
    • “The Road to Hell is Paved with Good Intentions” and eTMF Implementations…Anything in common?
      Lisa D. Mulcahy
      Owner, Principal Consultant
      Mulcahy Consulting, LLC, United States
    • How to Prepare for an eTMF Inspection
      Wendy Trimboli
      Eisai Inc, United States
  • 3:30PM - 5:00PM (Central Europe Standard Time)

    PREPARING FOR THE IMPLEMENTATION OF ISO IDMP


    Session Chair(s):

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

    The legislative deadline of July 2016 for implementation of the International Organisation for Standards (ISO) standards for Identification of Medicinal Products (IDMP) is rapidly approaching. The session will cover the current status and agency plans and expectations, the general position of industry regarding the ability and readiness to implement and an assessment from one company of their approach to assessment of the impact and preparing for implementation.

    Speaker(s):

    • EU Agencies’ Plans and Preparation for the Implementation of IDMP
      Thomas Balzer
      BfArM, Germany
    • IDMP: The challenges for industry to address implementation in the EU
      Remco Munnik
      Regulatory Information Director
      Asphalion S.L., Spain
    • Planning for IDMP: One company’s approach to preparation
      Rolf Brockmeyer
      Bayer Pharma AG, Germany

Day 2 Wednesday, Dec 03, 2014

  • 8:00AM - 8:30AM (Central Europe Standard Time)

    WELCOME COFFEE IN THE REGISTRATION AREA
  • 8:30AM - 10:00AM (Central Europe Standard Time)

    BRINGING THE REFERENCE MODELS TO LIFE!


    Session Chair(s):

    • Steve Scribner
      Principal Consultant - Life Sciences
      EMC, United States

    The Document and Records Management (DRM) community of the DIA has been busy since 2009 in the formation and update of Reference Models (RM) for document and content management. The currently published editions for both the eDM and the Trial Master File (TMF) Reference Models are available on the DIA website – eDM Corner. To keep those models updated to reflect the transformation of business processes, many updates and extensions are being prepared to keep them relevant as well as to harmonise and include additional process threads. The current state of both models (eDM & TMF) will be discussed, how they are interrelated and where they are being extended. This session will also include an overview of the model evolution and other industry standards development. A short synopsis of the recently released TMF Metrics Model and the annual TMF industry survey will be included. Experts from the eDM RM Core Team and TMF RM Steering Committee will deliver hands-on practical advice about model adoptions; including an interactive TMF RM best practice discussion / Q&A session with attendees, which will drive TMF RM V3.0 activities.

    Speaker(s):

    • Karen Roy, MPharm
      Global Business Development Director
      Phlexglobal Ltd, United Kingdom
    • Lisa D. Mulcahy
      Owner, Principal Consultant
      Mulcahy Consulting, LLC, United States
    • Fran Ross
      Associate Director, Clinical and Regulatory Optimization
      Paragon Solutions, United States
  • 8:30AM - 10:00AM (Central Europe Standard Time)

    BUSINESS MODELS TO GET THE REGULATORY WORK DONE


    Session Chair(s):

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

    The nature of regulatory work is getting more complex as time goes on. Resources are constrained and new models are being employed to get the work done in a more efficient manner. This session will look at the challenges and opportunities being addressed currently including outsourcing, dossier content management and how to address process, technology and resource management.

    Speaker(s):

    • Managing the Interfaces, Processes and Future Expectations in an Outsourcing Relationship
      Sophie Daniel
      Senior Consultant
      ProductLife Group, France
    • Harmonisation and Standardisation of Dossier Content, Information and Processes.
      Katy Juliet Page, MBA
      Senior Director Submissions and Operations Support
      Pfizer Ltd, United Kingdom
    • Harmonisation and Standardisation of Dossier Content, Information and Processes.
      Monique Rivas
      CEO
      LUZ Inc, Switzerland
    • Synergies for Managing Regulatory eStrategy: Business process, technology, and resourcing
      Cynthia F. Piccirillo
      Group Director, Global Dossier Management eStrategy
      Bristol-Myers Squibb, United States
  • 10:00AM - 10:45AM (Central Europe Standard Time)

    COFFEE BREAK IN THE EXHIBITION AREA
  • 10:45AM - 12:15PM (Central Europe Standard Time)

    END-TO-END DIGITAL CONTENT AVAILABILITY


    Session Chair(s):

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

    END-TO-END DIGITAL CONTENT AVAILABILITY

    Speaker(s):

    • Enabling the new drug development paradigm through collaboration and interchange
      Paul Fenton, MBA, MS
      President & CEO
      Montrium, Canada
    • How Readily Available is Your eTMF?
      Dorte Frejwald Christiansen
      Life Science Advisory Advanced Business Consultant
      NNIT, Denmark
    • Digital Preservation for Pharma: Comprehensive standard or flexible?
      Pauline Sinclair
      Digital Archiving Consultant
      Preservica Ltd , United Kingdom
  • 12:15PM - 1:30PM (Central Europe Standard Time)

    LUNCH IN THE EXHIBITION AREA
  • 1:30PM - 2:30PM (Central Europe Standard Time)

    RISK-BASED APPROACHES TO ENSURE DATA INTEGRITY


    Session Chair(s):

    • Peter Schiemann
      Widler & Schiemann Ltd, Switzerland

    In this session, participants will learn about the general concept of utilising information in the clinical development environment and how this concept is being put into practice by different organisations.

    Speaker(s):

    • eDM as Foundation for Managing Clinical Trials
      Peter Schiemann
      Widler & Schiemann Ltd, Switzerland
    • ACRES
      Greg Koski, MD, PhD
      President and CEO, Co-Founder
      Alliance For Clinical Research Excellence and Safety (ACRES), United States
  • 2:30PM - 3:30PM (Central Europe Standard Time)

    ACHIEVING COMPLIANCE WITH ELECTRONIC SYSTEMS- THE REGULATOR’S PERSPECTIVE


    Session Chair(s):

    • Gunnar Danielsson
      Senior Regulatory Advisor
      Pharma Consulting Group, Sweden

    Ownership and control of electronic clinical trial data and documents is clearly defined in the regulations, whether it is the data (electronic data capture) or the documents (electronic investigator site file). However with the move to cloud-based systems, more and more sponsors are maintaining control of the systems, and therefore the access, meaning that the Investigators can no longer show their ownership. This extends from eSource to live trial systems to electronic archiving and is not in compliance to the Regulators requirements. In this session, the views and perspectives of FDA and EMA (via the Danish Health and Medicines Agency) will be provided.

    Speaker(s):

    • Jonathan S. Helfgott, MS
      Associate Director for Risk Science (Acting), OSI, OC, CDER
      FDA, United States
    • Philip Lange Moller
      GCP Inspector
      Danish Health and Medicines Authority, Denmark

Exhibits  

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.   

 

Download Application Form

 

For more information on exhibiting space and facilities, please contact Roxann Schumacher at DIA Europe on

+41 61 225 51 38 or email: Roxann.schumacher@diaeurope.org

 

  • arivis AG
  • Cunesoft
  • EMC
  • ENNOV Group
  • EXTEDO GmbH
  • fme AG
  • FormPipe
  • INFOTEHNA Group LLC
  • LORENZ Life Sciences Group
  • Montrium, Inc.
  • PAREXEL International
  • Phlexglobal Inc
  • Pilgrim Quality Solutions
  • ProductLife Group
  • QUMAS

Registration Fees 

Member

Member Academia
€725.00
Member Government
€725.00
Member Standard
€1450.00

Non-Member

NonMember Academia
€855.00
NonMember Government
€855.00
NonMember Standard
€1580.00
Registration Fees for Additional Offerings
01 - ELECTRONIC TRIAL MASTER FILES (eTMF) - MOVING FROM - Industry Rate
€550.00
02 - UNDERSTANDING THE IMPACT OF IDENTIFIC - Industry Rate
€550.00
Group Discounts

Group Discounts Available – Send 3 participants and the 4th is free!

Conditions apply. Online registration not available for group discounts. Call DIA in Europe on +41 61 225 51 51 or email for further information.

Register Online
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