140.633.81
Biostatistics in Medical Product Regulation
Location
Internet
Term
1st Term
Department
Biostatistics
Credit(s)
2
Academic Year
2012 - 2013
Instruction Method
TBD
Available to Undergraduate
No
Grading Restriction
Pass/Fail
Course Instructor(s)
Mary Foulkes
Simon Day
Frequency Schedule
Every Year
Resources
Prerequisite
Basic epidemiology and biostatistics
Provides a broad understanding of the application of biostatistics in a regulatory context. Reviews the relevant regulations and guidance documents. Includes topics such as basic study design, target population, comparison groups, and endpoints. Addresses analysis issues with emphasis on the regulatory aspects, including issues of missing data and informative censoring. Discusses safety monitoring, interim analysis and early termination of trials with a focus on regulatory implications.
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