DDA1b Writing Submission Dossiers using the Common Technical Document

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

Participant 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.