#54: Art of Writing a Clinical OverviewDay & Time:
June 23, 9:00AM - 5:00PMRoom Number:
259ADescription:Maximize your learning while attending the DIA 2013 49th Annual Meeting! Receive $100 off of your DIA 2013 meeting registration by registering for two half day tutorials or one full day tutorial. Purchases must be made at the same time in order to receive the discount.
This tutorial 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).
What you will learn:
• 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
• 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
• How to develop the Clinical Overview for other types of submissions.
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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 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
This tutorial is designed for clinical research and development professionals, medical writers, and regulatory affairs personnel involved in the preparation or review of Module 2.5 of a CTD.