The Center for Professional Innovation & Education, Costa Mesa, CA
June 14 & 15, 2007
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.
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 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
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.