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Overview

16th DIA Conference on European Electronic Data Management and eHealth Topics -
Stop Paper Thinking!

Pre-Conference Tutorials, 23 May

Add one of two tutorial to your conference registration, to round off your learning experience and maximise the benefit of your attendance.

  • Tutorial 1: Electronic Trial Master Files (ETMF) - More Than a Document Repository
  • Tutorial 2: Regulatory Information Management and Identification of Medicinal Products (IDMP)

Separate Registration Required

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Conference, 24-25 May

The only conference focused on Electronic Content Management that brings together both regulatory agencies and industry to discuss the shift away from paper documentation. Sessions and speakers provide a life cycle approach to discussing all aspects of content management from documentation writing, through internal and external reviews and submissions, its use in line-of-business applications, and ultimately to archiving.

Come and learn about the benefits and constraints associated with the question "how do we reduce our reliance on paper documents"

  • Increase your network of interdisciplinary experts
  • Come away with insights into the bigger picture of the issues at hand for eDM
  • Increase your exposure to new technologies and ideas aimed at improving your everyday work

Programme Sessions are still in development, however, Highlight Topics include:

  • Integrating eTMF and enterprise content/ document management
  • Interoperability (e.g. eTMF with eTMF, eTMF with eDM, eTMF with data warehouse)
  • eSubmission (eCTD 4.0)
  • Portals, common repositories and gateways
  • Maintenance of XEVMPD and labelling management
  • Preparing for IDMP
  • Outsourcing and Infrastructure
  • CRO Integration of processes
  • Outsourcing and Infrastructure

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

Learning objectives

Come and learn about the benefits and constraints associated with the various topic-related processes and contribute to answering the question how to stop paper thinking.

Program Committee

  • Karen Jane Roy, MPharm
    Karen Jane Roy, MPharm Senior Vice President, Client Solutions
    Phlexglobal, United Kingdom
  • Hans  van Bruggen, MSc
    Hans van Bruggen, MSc Regulatory Affairs Scientist
    eCTDconsultancy B.V., Netherlands
  • Eldin  Rammell
    Eldin Rammell Managing Director & Principal Consultant
    Rammell Consulting Ltd, United Kingdom
  • Andrew P. Marr, PhD
    Andrew P. Marr, PhD Managing Director
    Marr Consultancy Ltd, United Kingdom
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+41 61 225 51 51


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