Market authorization in eCTD format training course.
When a pharmaceutical company has completed all the required research to support approval for marketing authorization, regulatory personnel must submit an application for licensing to the relevant regulatory agencies in the correct format.
The preferred format in most countries is the electronic common technical document (eCTD) format. The application may be simple or complex.The complexity depends on the on the drug.
In this course we will discuss the regional requirements as well as the common eCTD format requirements in Canada, USA and EU.
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