PHAR 533 Medical Writing NDA Clinical Modules

Writing the clinical documents of a standard new drug application (NDA) requires an understanding of the drug development process, a strong grasp of scientific principles and the ability to write clearly and effectively. It also requires a grasp of the type of data included in each module as well as the key purpose each section serves. This hands-on course for clinical and regulatory-focused individuals in the pharmaceutical industry will allow application of skills to the clinical documents in an NDA submission. This course will focus on learning how to interpret and organize clinical data and write standard clinical documents in an NDA submission.




Permission of the instructor