Introduction to Effective Medical Writing

Clear, readable medical writing verifies product integrity. It provides a history of product development as companies publish study results in professional journals and submit documentation to regulatory agencies. If the writing is good, it is also cost effective. In the clinical setting it can help prevent the need for additional costly clinical trials, which agencies can require if documents don’t accurately reflect sound science or technology. Poor writing frequently slows the review process as well as regulators ask for clarification and additional documentation, while well-written submissions optimize the review process and increase the amount of time a product remains under patent protection. This course provides an overview of how to present product information clearly and concisely for targeted audiences. Hands-on exercises reinforce the course content.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.