Spring Intro 2023

Jenny Lamport

Overall content…

 Trying to fit information on some products to all areas of the CTD format can lead to a lot of repetition, and a larger dossier than necessary

 Ensure that sections are linked and consistent

The Organisation for Professionals in Regulatory Affairs

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Types of application

Full applications

● Complete information

‘Abridged’ applications ● Cross-reference to information submitted previously

The Organisation for Professionals in Regulatory Affairs

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