140.633.81
Biostatistics in Medical Product Regulation
Location
Internet
Term
1st Term
Department
Biostatistics
Credit(s)
2
Academic Year
2024 - 2025
Instruction Method
Asynchronous Online
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Pass/Fail
Course Instructor(s)
Contact Name
Frequency Schedule
Every Year
Resources
Prerequisite
Basic epidemiology and biostatistics
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
This course is evaluated as follows:
- 15% Quizzes
- 10% Discussion forum
- 10% LiveTalk participation
- 65% Final Project