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Instructor Class Description

Time Schedule:

Roberta J Wong
BIOEN 599
Seattle Campus

Special Topics in Bioengineering

Offered at a graduate level periodically by faculty members within the Department of Bioengineering; concerns areas of research activities with current and topical interest to bioengineers. Prerequisite: undergraduate or graduate courses (or equivalent) determined individually for each special topic.

Class description

Course Description: This clinical development course reviews the major concepts under which clinical trials are designed and implemented. The themes of ethical treatment of human subjects and Good Clinical Practice (GCP) are emphasized. Topics include: phases of clinical trials, the role of the Food and Drug Administration and Institutional Review Boards, and ethical principles, including informed consent and conflict of interest. During the course, each student will develop a life cycle plan for an investigational product and also work on a team with other students to prepare a pre-NDA presentation on an investigational product. V

Student learning goals

List the major sections of a target product profile

Discuss the role of the FDA in approving drugs for the US market

Describe drug efficacy and safety

Review the function of an Institutional Review Board and how they impact clinical trial subjects

List the components of a product life cycle plan and discuss how this is used for drug development

General method of instruction

A combination of live lectures, recommended reading, case studies and discussion will be utilized in this course.

Recommended preparation

All students will have completed the basic biosciences coursework.

Class assignments and grading

Students will create a target product profile, and work in teams to create a group presentation. Time will be given in class to work on group presentations.

Grading will be based on the writing assignments and the oral presentations.


The information above is intended to be helpful in choosing courses. Because the instructor may further develop his/her plans for this course, its characteristics are subject to change without notice. In most cases, the official course syllabus will be distributed on the first day of class.
Last Update by Roberta J Wong
Date: 09/20/2011