Spring Intro 2023

Jenny Lamport

Conclusions

 Plan the structure of the CTD as early as possible

 This can be done before actual data are available

 Optimise granularity for the future

 Consider all uses of the document

The Organisation for Professionals in Regulatory Affairs

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Topics covered

Marketing authorisation applications ● Legislative background ● Format and data content – Common technical document (CTD) ● Types of application

The Organisation for Professionals in Regulatory Affairs

46

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