Module 1 2021

25/06/2021

What are the Challenges of Electronic Submissions?

The Organisation for Professionals in Regulatory Affairs

9

What are the challenges of electronic submissions?

1. Standards for the documents 2. Standards for the dossiers • The structure of the dossier: eCTD and NeeS • Technical validation of the submissions 3. The need for tools to be able to create and manage the submissions 4. A technical understanding of the tools and formats

The Organisation for Professionals in Regulatory Affairs

10

5