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Art of Writing a Clinical Overview


This On Demand Training will take approximately 6 hours to complete.

DIA is pleased to present this introductory online training course which will provide 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).

Featured topics

  • Objectives, structure, and format of the Clinical Overview, with attention given to developing a document suitable for multi-region submissions
  • Inclusion and presentation of clinical and nonclinical data, 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
  • How to frame the different sections of the Clinical Overview to best communicate the product’s unique attributes
  • Identify how to develop the Clinical Overview for other types of submissions

Who should attend?

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

Learning objectives

At the conclusion of this activity, 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 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

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