• 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

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

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