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.
If you are interested to register for the workshop, please contact us at email@example.com.
Please indicate whether you are interested to register for an individual use or for a team.
- 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.
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)