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Regulatory Submissions, Information, and Document Management Forum


Session 2 Track 3: EDMS in the 21st Century, Better, Broader, More Flexible

Session Chair(s)

Dimitri  Stamatiadis, PhD, MBA

Dimitri Stamatiadis, PhD, MBA

  • CEO
  • Maia Consulting, Switzerland
EDMS has been around for a long time and appeared to have reached a quiet maturity. But technology has once more surprised us, and in more than one way. In the past few years EDMS moved to the cloud, became metadata driven and adopted a flexible cost model. At the same time, new content came onboard with the addition of eTMF triggering additional functionality. But if regulatory documents are organized with CTD dossier submission in mind, how can other documentation be transferred to HAs? Are we getting ready to submit eTMFs? Finally, EDMS technologies have become accessible to smaller companies thanks to a flexible cost model and the development of standards such as the DIA reference models. Now, small companies have Pocket EDMS, a free, simple, standardised protocol for choosing the right vendor also developed within the DIA framework. Definitely EDMS is alive and kicking.
Learning Objective : • How regulatory affairs can become more involved in defining what and how content is provided for electronic submissions. • Understanding the complexity of TMF and the components that impact regulatory affairs. • How do communicate documentation needs to content from clinical to regulatory for eCTD submissions

Speaker(s)

Dimitri  Stamatiadis, PhD, MBA

Pocket EDMS a DIA initiative for Small and Medium Pharma and Biotech

Dimitri Stamatiadis, PhD, MBA

  • CEO
  • Maia Consulting, Switzerland
Rick  London

The Future of DMS Design and User Experience

Rick London

  • Product Manager
  • GlobalSubmit, United States
Patricia  Santos-Serrao, RAC

Bringing TMF and eCTD Together: Is Your TMF Submission Ready?

Patricia Santos-Serrao, RAC

  • Director of Product Management, Pharmaceuticals and Biologics
  • MasterControl, United States