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Course Description:

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.

Key Learning Objectives:

1. Understanding the structure of the common technical dossier in relation to bioanalytical content
2. Identifying the module locations for source reports
3. Determining the summary sections with bioanalytical authoring requirements
4. Identifying the sections and impact of bioanalytical review
5. Incorporating authoring strategies to support reviewer

Topics covered include:

1. Origin of the Common Technical Document
2. Structure of the Common Technical Document
3. Bioanalytical Contributions to Nonclinical Sections
4. Bioanalytical Contributions to Clinical Sections
5. Tips on Authoring Summary Modules
6. Additional CTD Sections for Bioanalytical Scientist Review

This training video will provide valuable information to:

1. Bioanalytical Leads on Programs
2. Bioanalytical Sciences Management
3. Regulatory Affairs and Project Managers
4. Consultants

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