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Art of Writing a Clinical Overview

 
  March 01, 2011  
     
 
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
 
 
Organized by: DIA
Invited Speakers: See website for speaker information
 
Deadline for Abstracts: Call contact
 
Registration: For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108 
E-mail: colleen.buckley@diahome.org
 
   
 
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