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.
Our hands-on course for clinical and regulatory-focused individuals in the pharmaceutical industry will allow you to apply your skills to the clinical documents in an NDA submission. This 8-week course will focus on learning how to interpret and organize clinical data and write standard clinical documents in an NDA submission. Also covered is an overview of the NDA’s role in the drug approval process and the guidelines and regulations that dictate the content of an NDA. Lead medical writer responsibilities will be covered as well as hands-on exercises for a key essential clinical NDA submission document. Additional insights into the tools of the trade are also integrated into the course material.
This is an excellent program for:
At the end of this course, students will have a foundation in the requirements for writing clinical documents in a standard NDA submission. Additionally, the student will gain hands-on experience with some of the complex aspects of presenting clinical data.
A total of 8 weeks is needed for completing the program.
A BS in the life sciences field, graduate level education is preferred.* Experience in pharma is a plus.
Experience in writing regulatory documents for drug development (CSRs and Protocols experience required) OR completion of The Fundamentals of Medical Writing. (MMSU MW1 Course)
Must have a strong understanding of Microsoft Office®.
Knowledge checks will be assessed through a quiz in every session. Evaluation of written reports will be assessed through multiple assignments/exercises and will conclude with a final examination. A minimum of 75% is required to pass the final examination.
* Degrees or diplomas from educational institutions outside the United States must be equivalent to degrees from U.S. educational institutions.