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The CTD Clinical Summary

Level:
Advanced
Area:
Drug Development
Code:
DDA3
Duration:
03:30:00
Workshop profile:
This workshop is aimed at writers with experience in writing clinical study reports but who are new to writing CTD Clinical Summaries.
Objective:
The purpose of this workshop is to look at creating the optimal CTD Clinical Summary that achieves its purpose. On completion of the workshop package, participants should be able to approach writing a CTD Clinical Summary with a better understanding of the expectations of a Regulatory Authority Assessor.
Content:
The workshop will begin with a brief presentation on what the CTD Clinical Summary is and where it fits in to the overall clinical dossier. This will then be followed by a review of the Clinical Summary structure and the important points within each section. This will then be followed by a review of some example data packages and a group discussion will take place to decide the best way of presenting the data. Finally, there will be a review and summary of the key messages to bear in mind when writing a CTD Clinical Summary.