This basic training course 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).
Course Level: Beginner
What you will learn
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
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