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Course Catalog

140.633.81 Biostatistics in Medical Product Regulation

Cancelled

Department:
Biostatistics
Term:
1st term
Credits:
2 credits
Academic Year:
2017 - 2018
Location:
Internet
Auditors Allowed:
No
Grading Restriction:
Pass/Fail
Contact:
Mary Foulkes
Course Instructors:
  • Mary Foulkes
  • Simon Day
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 global product development.

Learning Objectives:

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 quizzes and exercises

Instructor Consent:

No consent required