Date(s) And Time(s):
Jun 19 2011 8:30AM - Jun 19 2011 5:00PM
2301 South Lake Shore Drive
Chicago, IL 60616-1497
This 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).
• The objectives, structure, and format of the Clinical Overview is explored, with attention given to developing a document suitable for multiregion submissions.
• The inclusion and presentation of clinical and nonclinical data are discussed in detail, 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.
• Specific examples are provided regarding how to frame the different sections of the Clinical Overview to best communicate the product’s unique attributes.
• While the course emphasis is on developing the Clinical Overview for a new chemical entity, insight into developing the Clinical Overview for other types of submissions will be provided.
At the conclusion of this training course, 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
• Clinical research and development professionals
• Medical writers
• Regulatory affairs personnel involved in the preparation or review of Module 2.5 of a CTD
For detailed program information including faculty and topics, please contact: