The Art of Writing a Clinical Overview

Venue: Pennsylvania Convention Center

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Jun 24, 2012 End Date/Time: Jun 24, 2012
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Overview This course takes a practical approach to creating clinical study reports, from data collection to final approval. Learn how to prepare a Clinical Overview for pharmaceutical products (drugs and biologics). In accordance with International Conference on Harmonisation (ICH) guidelines, this in-depth course provides all the information on how to develop Module 2.5 of a Common Technical Document (CTD).

What You Will Learn
Objectives, structure, and format of the Clinical Overview, including how to develop a document suitable for multiregion submissions
Presentation of clinical and nonclinical data and how to effectively use the other technical summaries within the CTD
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 communicate the product’s unique attributes
How to repurpose the Clinical Overview for other submissions

Who Should Attend
Clinical research and development professionals
Medical writers
Regulatory affairs personnel involved in the preparation or review of Module 2.5 of a CTD
Learning Objectives Participants who complete this course 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

Patricia A. Matone, PhD
Scientific Information Services LLC, United States


1101 Arch Street
United States