Who Should Attend

This course is valuable to those who write or review documentation in support of clinical trials and regulatory submissions.  It will also benefit professionals who prepare or review articles and abstracts about therapeutic products in any phase of development for professional publication.  The course is particularly helpful for those new to the discipline and wish to understand the scope of medical writing. Typical attendees include medical writers, reviewers of medical documents, clinical research managers and associates, regulatory affairs professionals, project physicians and medical monitors.

Learning Objectives

Upon completion of this course you will understand:

• What medical writing encompasses
• How to write documents that meet the company’s goals and objectives
• Why publishing is an essential part of therapeutic product position
• How to write an abstract or manuscript
• How to control sentence structures for precise delivery of data
• How to increase clarity and effectiveness through tone and voice
• How to create effective data displays
• The role of the writer in producing and issuing documents
• How to overcome Writer’s Block
• How to produce documents within controlled timelines
• The best ways to manage the review process
• What kind of feedback is useful to other writers
• How to reach concurrence in the review process

 


Course Description

High-quality medical writing, which has a multi-million dollar impact on a company’s financial performance, can prevent the need for additional clinical trials which are often required because of unclear communication and poorly written documents.  Good medical writing can lead to optimal product labeling, allowing successful product promotions and maximization of advertising claims.

Well written submission documentation can decrease the length of the product marketing approval process and increase the amount of time a product can be sold under patent protection.  This course provides an overview of how to present product information clearly and concisely for the targeted audience.  Hands-on exercises reinforce the course content.

View Course Agenda



Past Participants' Comments

“The in-depth clinical study report analysis and class participation for the writing exercises increased my understanding and confidence with the medical writing process."
Anthony P., Medical Writer, Averion

“An excellent orientation for new writers as well as detailed, comprehensive strategies for successful submissions that will be useful for experienced medical writers.”
Diahann H., Consulting Medical Writer, Abbott

“The course went above and beyond my expectations.  It was extremely informative and the instructors were knowledgeable and dynamic."
Marie V., Project Coordinator, SuperGen

“As a Document Specialist for Novartis, who reviews protocols and study reports to ensure that they meet all FDA and internal guidelines, I found this course to be extremely helpful and informative.  The course afforded me a better understanding of the details of writing a Study Report.  I will inform my management of how important this course will be to help all new hire, as well as, seasoned scientists become more effective writers."
Theresa M., Document Specialist, Novartis