140.633.81
Biostatistics in Medical Product Regulation
- Location:
- Internet
- Term:
- 1st term
- Department:
- Biostatistics
- Credits:
- 2 credits
- Academic Year:
- 2022 - 2023
- Instruction Method:
- Asynchronous Online
- Auditors Allowed:
- No
- Undergrads Allowed:
- No
- Grading Restriction:
- Pass/Fail
- Course Instructor:
-
- Chenguang Wang
- Contact:
- Chenguang Wang
- Resources:
- Prerequisite:
Introduction to Online Learning is required prior to participating in any of the School's Internet-based courses. Basic epidemiology and biostatistics
- Description:
-
Addresses the application of many principles of biostatistics in the context of medical product development and regulation. Provides a basis for understanding international regulation as outlined in various guidance documents. Opportunities provided through presentations and discussions to learn about applications to study design, conduct, analyses, and inferences. Presents examples of products, product development processes, and opportunities for innovation in clinical trial design and analysis.
- Learning Objectives:
-
Upon successfully completing this course, students will be able to:
- Explain the relevance and application of statistics to the regulatory process
- Differentiate between well-designed and conducted clinical research in the development and evaluation of new medical products
- Locate internet sources for regulatory requirements, and regulatory review and evaluation information
- Methods of Assessment:
Class quizzes and exercises and a course project
- Instructor Consent:
No consent required