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Writing Global Submission Dossiers using the Common Technical Document

Level:
Advanced
Area:
Drug Development
Code:
DDA1a
Duration:
03:30:00
Workshop profile:
The course is intended for medical writers with little or no experience of writing clinical submission dossiers although participants should be familiar with the clinical development process and have had some experience of writing clinical study reports.
Objective:
• To introduce participants to the preparation of clinical submission dossiers according to the CTD • To convey general principles and process of summary writing • To facilitate understanding of the limits of the available regulatory guidance
Content:
• Development and background of the CTD • Purpose and types of clinical summary documents • CTD Module 2.5 (Clinical Overview) • CTD Module 2.7 (Clinical Summary) • Integrated summaries of efficacy and safety for the USA