Module 1 2021

25/06/2021

Document Standards

• Basic standards for electronic documents are included in the eCTD specification • Create documents from an electronic source and convert this directly to PDF • Create templates for your documents to standardise and control the content of the documents ─ This also makes conversion to PDF easier • Avoid scanning paper and don’t get caught up in trying to create searchable text (OCR) • Train your writers to use MS Word properly! ─ Many people have never been on a course about their main authoring tool

The Organisation for Professionals in Regulatory Affairs

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Dossier standards: eCTD and NeeS

• The electronic Common Technical Document ( eCTD ) and the Non-eCTD eSubmission ( NeeS ) format are two of the more widely used formats • The following slides provide more detail about these submission formats

The Organisation for Professionals in Regulatory Affairs

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