Introduction to Effective Medical Writing™

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.

Who Should Attend

This medical writing training 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

Past Participants' Comments

"CfPIE organizes a great course! The Course Director provides excellent material. She gave great examples, and supported them during workshop activities. She also invites questions for future follow-up. It has been a pleasure to return to CfPIE for a new course topic and have a familiar instructor that was enjoyable the first time. I'm looking forward to my next course and eventually completing my certification." Karin B., Technical Writer III, Gen-Probe

"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

"Very useful course! The review of basic language and grammar concepts such as active/passive voice, parallel form, use of punctuation, etc. was very helpful as these concepts have not been reviewed since middle school. Appropriate pace throughout the course and also great discussion among attendees. The Course Director is a great teacher and really engaged students. Thank you!." Anupma R. – Post Doctoral Fellow – Cubist Pharmaceuticals

"The course went above and beyond my expectations. It was extremely informative and the instructor was 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 hires, as well as, seasoned scientists who need to become more effective writers." Theresa M., Document Specialist, Novartis

"Best presentation on Medical Writing ever!" Diane B., Coley Pharmaceuticals

"I enjoyed the Course Director's presentation and communication. I gained a wealth of knowledge . I know have a better understanding of the writing process." Joanne A., Sr. Med Affairs Coord, Bayer Healthcare Pharmaceuticals

"Content – Perfect balance; Director – They don't get any better; Group make-up – Very good for input, contribution, and contacts." Colette L., MD, FRCPC, CRC Partners STD

"This was an excellent course for me in my current work in protocol review and leading medical imaging charter development. The group sessions were helpful to gain an alternative thinking and writing approach. I will definitely attend future CfPIE courses and encourage my leadership to send my colleagues." De Jane H., Director, Medical Imaging, Amgen

"The Course Director provided very useful information and outside references, and offered continued assistance and resources after the conclusion of class. Great instructor, great class." Darlene N., Sr. Process Engineer, Covidien

"The Course Director was wonderful! Her teaching style was extremely friendly and informative. It was refreshing to see genetics examples of medical writing in our class, which is my specialization. I will return to take the other medical writing courses for the certification program. Thanks again to the Course Director and your staff who were pleasant and provided excellent service." Valerie K., Clinical Documentation Specialist II, Alexion Pharmaceuticals