Gaylord National Hotel and Convention Center , National Harbor, MD USA
Feb 14 2011 7:00AM - 3:00PM
Practical Approach to Creating Clinical Study Reports from Data Collection to Final Approval
This course 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). What you will learn: · 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 · How to develop the clinical overview for other types of submissions Event Code:
11401
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