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).
- 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
- Clinical operations professionals
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