Module 1 2021

25/06/2021

Main components of a NeeS

The Organisation for Professionals in Regulatory Affairs

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Main components of a NeeS • Leaf Documents ─ The files with the information

• Only PDF files ─ [Using the eCTD standards and file naming]

• A Directory Structure

─ Somewhere to put all of the files ─ [The same structure as the eCTD]

• A PDF Table of Contents ─ A way to navigate the structure to the individual content files ─ No lifecycle management capabilities

The Organisation for Professionals in Regulatory Affairs

22

11