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.
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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
"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
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