CTD

Course Objectives

1- Explain the history and need for CTD as an international regulatory working standard.

2- Clarify the granularity of CTD format dossiers according to ICH guidance.

3- Illustrate the scientific data needed to complete each part & create a strong CTD file submission.

4- To train the participants to plan and prepare a successful CTD submission.

Course Outline

► Overview and history of CTD and e-Submissions.

CTD advantages against different types of submissions.

► CTD format outline (modules 1 – 5)

CTD submission workflow inside and outside the corporate.

CTD Module (1 – 5) in detail.

►Hard copy specifications and management.

CTD Example for registration in EDA. (Module 3)