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Art of Writing a Clinical Overview

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Overview 

This course takes a practical approach to creating clinical study reports, from data collection to final approval. Learn how to prepare a Clinical Overview for pharmaceutical products (drugs and biologics). In accordance with International Conference on Harmonisation (ICH) guidelines, this in-depth course provides all the information on how to develop Module 2.5 of a Common Technical Document (CTD).

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

    Contact Information 

    Jessica McGrory at +1-215-442-6182 or Jessica.McGrory@diahome.org

    Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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