140.633.11
Biostatistics in Medical Product Regulation
Course Status
Cancelled
Course Status
Cancelled
Location
East Baltimore
Term
Summer Institute
Department
Biostatistics
Credit(s)
2
Academic Year
2012 - 2013
Instruction Method
TBD
M, Tu, W, Th, F, 8:30 - 11:50am
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Mary Foulkes
Contact Name
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.