McCormick Place, Chicago, IL
Jun 19 2011 8:30AM - Jun 19 2011 5:00PM
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. Event Code:
11402
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