Regulatory agencies expect nonclinical and clinical data to be presented and summarized in a consistent manner across all sponsors. This applies to the investigational new drug (IND) application in the US as well as the drug approval applications [biologics license application (BLA) and new drug application (NDA) in the US, the marketing authorization approval (MAA) in EU, and Japan new drug application (J-NDA)].
The common technical dossier (CTD) structure presents the information in a consistent manner as developed by the International Committee of Harmonization (ICH). Within this structure, there are assigned locations for bioanalytical reports as well as structured summaries where high level conclusions should be presented.
This training walks the learner through the relevant sections of the CTD from a bioanalytical sciences perspective, providing guidance for both authoring and review sections.