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CTD Clinical Summary & Overview

This workshop is aimed at writers with experience in writing study reports but who are new to writing CTD Clinical Summaries and Overviews. The purpose of this course is to look at identifying the elements of an optimal CTD Clinical Summary and Overview that achieves its purpose and meets the expectations of a Regulatory Authority Assessor. The workshop will begin with a presentation on what the CTD Clinical Summary and Overview are and where they fit in to the overall clinical dossier. This will be followed by an overview of the Clinical Summary structure and the important points within each section. We will then review some data packages and we will discus in groups the best way of presenting examples of data. In the afternoon, the Clinical Overview will be reviewed, including an overview of the structure of the document and the important points to be included within each section. Pointers about what a regulatory reviewer wants from a Clinical Overview will also be included. 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.

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Since 1987, we have been delivering quality training to the pharmaceutical, healthcare, CRO and related industries. As well as delivering technical courses supporting clinical research functions, we also offer a wide range of personal development courses to ensure that skills learnt can be applied in the workplace.

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