This course is designed to present an introduction to the regulations and documents necessary for FDA approval of a new medical device or pharmaceutical product. The student will be introduced to federal regulations (CFR), human subject regulations, clinical trials and evidence based documents, clinical protocols, data management, clinical trial data, investigational review board and submissions of drug and device approval documents. An introduction to clinical and manufacturing process and standard operating procedure documentation will also be included.
- Recognize and understand FDA nomenclature.
- Understand the federal regulations in the approval process if a new drug or medical device.
- Understand clinical report forms.
- Have a fundamental knowledge of human rights obligations, adverse events, clinical trial monitoring and FDA forms.
- Recognize the appropriate forms for institutional Review Board approval.
- Understand the concepts of a clinical trial and the various phases of the clinical trial.
- Understand good manufacturing and good clinical processes.
Why Choose National University?
We’re proud to be a veteran-founded, San Diego-based nonprofit. Since 1971, our mission has been to provide accessible, achievable higher education to adult learners. Today, we educate students from across the U.S. and around the globe, with over 180,000 alumni worldwide.
Focus on one subject at a time — one month at a time — and finish your degree faster.
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Choose from associate, bachelor’s, and master’s degrees, plus credentials and certificates.
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Study when and where it’s convenient for you with evening, weekend, and 100% online classes.
Apply or transfer any time. Classes start monthly, and applications are accepted year round.
Attend class and learn onsite at one of over 20 locations in California.
As a Yellow Ribbon school, we offer tuition discounts to servicemembers and dependents.