http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr... Course

Date(s) And Time(s):
Feb 14 2011 7:00AM - Feb 14 2011 3:00PM

Location:
Gaylord National Hotel and Convention Center
201 Waterfront Street
National Harbor, MD 20745

Overview:

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

Learning Objectives:

At the conclusion of this course, 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:
11401

Contact Information:

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