Intro to Regulatory Affairs

Course Description

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.

Learning Outcomes

  • 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 150,000 alumni worldwide.

Four-Week Classes

Focus on one subject at a time — one month at a time — and finish your degree faster.

100+ Degree Programs

Choose from associate, bachelor’s, and master’s degrees, plus credentials and certificates.

On Campus or Online

Study when and where it’s convenient for you with evening, weekend, and 100% online classes.

Year-Round Enrollment

Apply or transfer any time. Classes start monthly, and applications are accepted year round.

20+ Campus Locations

Attend class onsite at one of over 20 campus locations across California or in Nevada.

Military Friendly

As a Yellow Ribbon school, we offer tuition discounts to servicemembers and dependents.

School of Health and Human Services

“Our faculty members are nationally recognized across a broad spectrum of health profession disciplines and prepare students for success in the ever-evolving health care field.”
School of Health and Human Services
Sarah H. and Caryl F.
Class of 2019, Military Servicemember and Class of 2019, respectively