En.605.704 May 2026

A: Expect 10–15 hours per week, including video lectures, readings (primary literature from NEJM , JAMA , and FDA dockets), and coding assignments.

Offered by the through its Engineering for Professionals (EP) program, EN.605.704 is formally titled "Real-World Data: Regulatory Science and Medical Device Applications." This graduate-level course bridges the gap between theoretical statistics, regulatory requirements from the FDA, and the practical analysis of real-world data (RWD) – information collected outside of traditional randomized controlled trials (RCTs). en.605.704

If you aspire to be at the intersection of data science and healthcare policy, or if you are an engineer who wants to see your device reach patients faster (and safely), this course provides the regulatory map and statistical tools to succeed. It is challenging, rigorous, and deeply practical. A: Expect 10–15 hours per week, including video

A: Yes. Non-degree seeking (NDS) students can register if they meet prerequisites and space is available. However, priority goes to degree-seeking students in the Applied Biomedical Engineering or Regulatory Science master’s programs. It is challenging, rigorous, and deeply practical

It transforms a messy spreadsheet of EHR data into a compelling, FDA-defensible story of safety and effectiveness. Disclaimer: Course content and availability subject to change. Always check the official Johns Hopkins University catalog for the most current syllabus, instructor information, and registration deadlines.