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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

 

Program Committee

  • Hans  van Bruggen, MSc
    Hans van Bruggen, MSc Director and Senior Regulatory Affairs Consultant eCTDconsultancy and Qdossier, Netherlands
  • Karen  Roy, MPharm
    Karen Roy, MPharm Chief Business Development Officer Phlexglobal, United Kingdom
  • Andrew P. Marr, PhD
    Andrew P. Marr, PhD Managing Director Marr Consultancy Ltd, United Kingdom
  • Eldin  Rammell
    Eldin Rammell Managing Director & Principal Consultant Rammell Consulting Ltd, United Kingdom
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Contact us

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