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.