DDA36 – NEW The non-clinical elements of the eCTD

Description

To introduce participants to the preparation of 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
Non-clinical summaries can often be challenging due to the number of studies to be presented and the nature for the studies utilising methods that the MW may not be familiar with.

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 non‑clinical and clinical development process. Preference is that participant also have had some experience of writing either non-clinical study reports or taken the EMWA course on non-clinical study reports.