Module 1 2021

25/06/2021

What are the benefits of an electronic submission?

• A reduction/elimination of paper • Ease of navigation • An electronic Table of Contents (TOC)

• Bookmarks • Hyperlinks

• Easy to search or query • Searching for documents • Searching the content of the documents (full text search) • Easy to copy information • A means to relate the information in a particular dossier to other submitted information • A means to relate a particular dossier to other dossiers

The Organisation for Professionals in Regulatory Affairs

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What is an electronic submission?

• Any set of files, in an acceptable format for the agency in question, that meets some or all of the benefits described earlier can be considered an “electronic submission”

• But clearly some electronic submissions are better than others!

The Organisation for Professionals in Regulatory Affairs

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