Biostatistics for Medical Products Regulation OpenCourseWare: Free Online Undergraduate Level Biostatistics Course by Johns Hopkins University

Published Dec 31, 2008

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'Biostatistics for Medical Products Regulation' is a free OpenCourseWare offered through John Hopkins University's Bloomberg School of Public Health. It provides an overview of the statistical principles and practices involved in the regulatory process intended to improve the safety and usefulness of medical products. This course is best suited for undergraduate students who are interested in public health careers or degree programs. Students interested in this course need to have completed courses in epidemiology and basic biostatistics prior to enrollment.

Biostatistics for Medical Products Regulation: Course Specifics

Degree Level Free Audio Video Downloads
Undergraduate Yes No No Yes

Lectures/Notes Study Materials Tests/Quizzes
Yes Yes No

Biostatistics for Medical Products Regulation: Course Description

The instructors for the 'Biostatistics for Medical Products Regulation' OpenCourseWare are Johns Hopkins University professors Mary Foulkes and Simon Day. Students will study use of statistics and quantitative thinking in medical product regulation. Through a series of eight lectures, course participants will be introduced to a variety of topics that related to the design, conduct and analysis of clinical trials and clinical studies. The evaluation and assessment process required of new medical devices and drugs is also covered. Each lecture includes a series of readings selected from industry-publications, FDA handbooks and scholarly journals. These readings are intended to help students understand the importance of biostatistics in the regulation of medical products. In addition, students will develop an understanding of how medical product tests are designed, from selection of sample sizes and populations to data collection (including the use of placebos) and analysis, along with the ethics of medical product regulation and testing.

Students can find lectures and study materials online. If you're interested in taking this free course, visit the biostatistics medical products regulation course page.

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