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The CTD Clinical Overview

Level:
Advanced
Area:
Drug Development
Code:
DDA5
Duration:
03:30:00
Workshop profile:
This workshop is aimed at writers with experience in writing study reports but who are new to writing Clinical Overviews for the Common Technical Document (CTD).
Objective:
The purpose of this workshop is to look at creating the optimal CTD Clinical Overview that achieves its purpose. On completion of the workshop package, participants should be able to approach writing a CTD Clinical Overview with a better understanding of the expectations of a Regulatory Authority Assessor.
Content:
The workshop will begin with a brief presentation on what a Clinical Overview is and how it fits into the dossier as a whole. This will then be followed by an overview of the Clinical Overview structure and the important points within each section. Finally there will be some pointers about what a regulatory reviewer wants from a Clinical Overview. Participants will then have the opportunity to take part in a group exercise drafting a Product Development Rationale section based on information provided in the workshop.