Medical Writing: Clinical Overview

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 multi-region 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 in to developing the Clinical Overview for other type of submissions will be provided.

At the conclusion of this tutorial, participants should be able to:

• Communicate the role of a Clinical Overview (Module 2.5) in a CTD
• Describe the structure and format of a Clinical Overview in accordance with ICH guidelines
• Develop strategies regarding the placement and presentation of information different sections of the Clinical Overview
• Explain how to effectively cross-reference to other components of the CTD
• Develop a submission-ready Clinical Overview that successfully communicates all available information concerning the benefits and risks of an investigational product
• Recognize how to modify the Clinical Overview for different submission types