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Course Catalog

140.633.11 BIOSTATISTICS IN MEDICAL PRODUCT REGULATION

Cancelled

Department: Biostatistics
Term: Summer Inst. term
Credits: 2 credits
Contact: Ayesha Khan
Academic Year: 2012 - 2013
Course Instructor:
Description:

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 Objective(s):

Upon successfully completing this course, students will be able to: 1) explain the relevance and application of statistics to the regulatory process; 2) differentiate between well-designed and conducted clinical research in the development and evaluation of new medical products; 3) locate internet sources for regulatory requirements, and regulatory review and evaluation information.


Methods of Assessment: Class exercises
Location: East Baltimore
Class Times:
  • Monday 8:30 - 11:50
  • Tuesday 8:30 - 11:50
  • Wednesday 8:30 - 11:50
  • Thursday 8:30 - 11:50
  • Friday 8:30 - 11:50
Enrollment Minimum: 10
Instructor Consent: No consent required
Prerequisite:

Basic epidemiology and biostatistics

Auditors Allowed: No
Grading Restriction: Letter Grade or Pass/Fail