This webinar is for CEP holders, applicants and other interested parties on the topic “Electronic Submissions for CEP applications”. This webinar follows the publication of the EDQM eSubmissions Roadmap for CEP applications and is based on EDQM experience of deficiencies frequently found during format validation of electronic applications.
The webinar describes the eSubmissions Roadmap for CEP applications with its major changes to current practices and key deadlines. There are also explanations on how to avoid common errors in submission of a CEP application in electronic format. Furthermore, the EU module 1 specifications version 3.0 for eCTD and the version 2.0 of the Common European Submission Portal (CESP) are presented with regards to CEP applications.
The goal of this webinar is to help applicants understand the EDQM eSubmissions requirements and reduce errors to obtain a faster procedure.
The presentations covers the following topics:
- eSubmission Roadmap for CEP applications
- Baseline submissions
- Main format issues
- EU Module 1 Specifications for eCTD (version 3.0)
- CESP version 2.0
Duration: 1 hour, 30 minutes
Target audience
This webinar is of interest to professionals working in regulatory affairs for pharmaceutical substances or medicines, and who prepare CEP applications.
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