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Virtual Classroom Trainings » Electronic Submissions in eCTD Format

Electronic Submissions in eCTD Format

Building an eCTD is a complex sub-project within a regulatory submission. While the technical standards of an eCTD have been developed by the ICH Expert Working Group, differing regional requirements for eCTD Module 1 information, differing eCTD (technical) validation criteria and various submission gateway set-ups have to be considered.

The present workshop is intended to provide an overview of the most important regional differences and address common pitfalls that can be avoided.

Moderation

The course will be conducted by Dr. Barbara Jentges, Senior Drug Regulatory Expert of Phact GmbH, who has a longstanding practical experience with eCTD submission projects.

Register Interest

If you are interested to register for the workshop, please contact us at info@phact.ch.

Please indicate whether you are interested to register for an individual use or for a team.

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Organisational

  • eCTD submission project
  • Regional differences
  • eCTD-compliant PDFs
  • eCTD lifecycle considerations

Dr. Barbara Jentges, Managing Director of Phact GmbH.

This workshop addresses experts from regulatory affairs and publishing departments that are involved in (global) eCTD submission projects. 

Please contact us for the next date.

half day (4 hours)

The course material will be provided to the participants at the beginning of the workshop.

CHF 450,00 excl. VAT (CHF 486,45 incl. VAT)

Each participant will receive a certificate of participation at the end of the workshop.
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