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This basic training 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).
Course Level: Beginner

What you will learn

  • Objectives, structure, and format of the Clinical Overview, including how to develop a document suitable for multiregion submissions
  • Presentation of clinical and nonclinical data and how to effectively use the other technical summaries within the CTD
  • How to prepare a document that successfully communicates the benefits and risks of the investigational product
  • How to frame the different sections of the Clinical Overview to communicate the product’s unique attributes
  • How to repurpose the Clinical Overview for other submissions

Who should attend?

  • Clinical research and development professionals
  • Medical writers
  • Regulatory affairs personnel involved in the preparation or review of Module 2.5 of a CTD

Learning objectives

Participants who complete this course 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 in 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