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Hotel Holiday Inn

2016年5月23日 (月) 午前 7:00 - 2016年5月25日 (水) 午後 5:00

Haagse Schouwweg 10, 2332 KG Leiden, Netherlands

16th DIA Conference on European Electronic Data Management and eHealth Topics

The only conference focused on Electronic Content Management that brings together both regulatory agencies and industry to discuss how to reduce reliance on paper documents?

概要

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

Download Programme

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

Featured

Want to learn more about 16th DIA Conference on European Electronic Data Management and eHealth Topics? You've come to the right site!

Continuing-Education

参加対象

  • 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

学習目的

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.

Short Course or Primer

To keep you at the forefront.

2016年5月23日 (月)

TUTORIAL 1 - ELECTRONIC TRIAL MASTER FILES (ETMF) – MORE THAN A DOCUMENT REPOSITORY:

2016年5月23日 (月)

TUTORIAL 2 - REGULATORY INFORMATION MANAGEMENT AND IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP):

プログラム委員会

  • Karen  Roy, MPHARM
    Karen Roy, MPHARM Chief Strategy Officer
    Phlexglobal, United Kingdom
  • Hans  van Bruggen, MSC
    Hans van Bruggen, MSC Director of Regulatory Affairs
    Celegence, United States
  • Eldin  Rammell
    Eldin Rammell Head of Quality Assurance
    Phlexglobal Ltd, United Kingdom
  • Andrew  Marr, PHD
    Andrew Marr, PHD Managing Director
    Marr Consultancy Ltd, United Kingdom

Digital Learning Catalog

DIA Learning: eLearning Soultions
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