Medical Writing of NDA Clinical Modules

Medical Writing of 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.

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.

Who Should Take This Course

This is an excellent program for:

  • A student or scientist interested in a career as a medical or regulatory writer in the pharmaceutical industry who has already completed the MMS Academy Course in the Fundamentals of Medical Writing.
  • A writer already working in the field that is interested in continued learning opportunities.

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.

Duration and Prerequisites

A total of 8 weeks is needed for completing the program.

Education and/or Experience
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.

System Requirements
Must have a strong understanding of Microsoft Office®.

Assessments
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.

Accreditation and Certification

This course is accredited by the Accreditation Council for Pharmacy Education (ACPE).

 

* Degrees or diplomas from educational institutions outside the United States must be equivalent to degrees from U.S. educational institutions.

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