Clinical Regulatory Affairs Program at the National University Learning Outcomes
- Understand the federal regulations in the approval process of a new drug, medical device, or biologic.
- Have a fundamental knowledge of human rights obligations, adverse events, clinical trial monitoring, and data collection.
- Develop and implement standard operating procedures, clinical data collection forms, electronic records, clinical trial protocols, and federal regulatory forms.
- Develop and implement a methodology for a clinical trial with supportive data management and data analysis.
- Design and implement an investigational device exemption and an investigational new drug application.
- Develop compliance documents and quality assurance and quality control documentation.
Get more detailsVisit official programme website
- You'll gain a comprehensive knowledge of the field, develop and implement appropriate protocols and documents, and understand data management and the clinical trial research industry.
- You’ll also learn how to effectively file for pre-market approval, new drug approval, or biologic license approval.
- 12 months
Start dates & application deadlines
DisciplinesPublic Health Human Medicine Health Sciences View 458 other Masters in Human Medicine in United States
We are not aware of any academic requirements for this programme.
- Applicants must hold a bachelor’s degree or higher from a regionally accredited college or university where an overall grade point average of 2.5 or better was achieved.
- Students with a grade point average of 2.0 to 2.49 may be admitted to the University if they have a satisfactory score on one of the following tests: GMAT, GRE, Miller Analogies Test, or an approved, standardized program-specific exam.
- Students with an undergraduate grade point average of 2.0 to 2.49 may be accepted to National University on a probationary status.
- Complete an application for admission and enrollment agreement.
International442 USD/moduleTuition FeeBased on the original amount of 442 USD per module and a duration of 12 months.
National442 USD/moduleTuition FeeBased on the original amount of 442 USD per module and a duration of 12 months.
cost per quarter unit
Studyportals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.
Apply and win up to €10000 to cover your tuition fees.
Due for update
Updated over a year ago
Check the official programme website for potential updates.