Module 1 2021

25/06/2021

What is an electronic submission?

• Some files? • A copy of an MS Word file of a labelling document • A PDF of a study report • A set of scanned images in a zip file • A set of PDF files with a linked Table of Contents • A full submission meeting the eCTD specification

The Organisation for Professionals in Regulatory Affairs

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What is an electronic submission?

• A submission format? • Files on a CD or DVD

• Files attached to an e-mail • Files submitted via Eudralink • Files submitted via CESP • Files submitted via a Gateway

The Organisation for Professionals in Regulatory Affairs

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