Region:  
 
      Advanced
Search 		 
Bookmark and Share 
  
Find An Educational Offering
Select Search Criteria
Keyword:
Events starting on or after:  mm/dd/yyyy
Events Added:
Region:
Interest Areas (IA): Hold the CTRL key to select or de-select multiple items from adjacent list box

     
Event Type: Hold the CTRL key to select or de-select multiple items from adjacent list box

 
 
© 2010 DIA  |  Home  |  Site Map  |  Contact Us  |  Terms and Conditions of Use  |  Disclaimer  |  Privacy Policy
  Click here to Expand the Tab 
10485 The Art of Writing a Clinical Overview - 3-part Online Training Series
 Overview 
 Registration Fees 
 Continuing Education 
 Related Offerings 
 Technical Requirement 
 Speakers 
Title:
The Art of Writing a Clinical Overview - 3-part Online Training Series

Date(s) And Time(s):
Oct 19 2010 11:30AM - Oct 21 2010 1:30PM

Interest Area(s):
Medical Writing,Clinical Research,Regulatory Affairs,Statistics

Overview:

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.



Learning Objectives:

At the conclusion of this online training series, 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



Target Audience:

• Clinical research and development professionals
• Medical writers
• Regulatory affairs personnel involved in the preparation or review of Module 2.5 of a CTD



Event Code:
10485

Contact Information:
For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108
Email Colleen.Buckley@diahome.org