Art of Writing a Clinical Overview
Venue: McCormick Place
|Event Date/Time: Jun 19, 2011|
â€¢ The objectives, structure, and format of the Clinical Overview is explored, with attention given to developing a document suitable for multiregion submissions.
â€¢ 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.
â€¢ Insight is provided on how to prepare a document that successfully communicates the benefits and risks of the investigational product.
â€¢ Specific examples are provided regarding how to frame the different sections of the Clinical Overview to best communicate the productâ€™s unique attributes.
â€¢ 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.