Art of Writing a Clinical Overview

Venue: McCormick Place

Location: Chicago, Illinois, United States

Event Date/Time: Jun 19, 2011
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This course provides an in-depth analysis of the preparation of a Clinical Overview for pharmaceutical products (drugs and biologics) in accordance with ICH guidelines concerning development of Module 2.5 of a Common Technical Document (CTD).

• The objectives, structure, and format of the Clinical Overview is explored, with attention given to developing a document suitable for multiregion submissions.

• The inclusion and presentation of clinical and nonclinical data are discussed in detail, with emphasis on how to effectively use the other technical summaries within the CTD.

• Insight is provided on how to prepare a document that successfully communicates the benefits and risks of the investigational product.

• Specific examples are provided regarding how to frame the different sections of the Clinical Overview to best communicate the product’s unique attributes.

• While the course emphasis is on developing the Clinical Overview for a new chemical entity, insight into developing the Clinical Overview for other types of submissions will be provided.

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