Course Description
In-depth topical exploration in regulatory science requiring the student to demonstrate expertise in a defined area of regulatory affairs, perform analytical techniques, and demonstrate decision-making used in practice to assure compliance with substantive BioPharma regulations.
Athena Title
Masters Seminar Regulatory Aff
Non-Traditional Format
This course will be taught 95% or more online.
Prerequisite
Permission of department
Grading System
S/U (Satisfactory/Unsatisfactory)
Course Objectives
This seminar course is designed to enable students to critically examine and evaluate current issues in biomedical and regulatory affairs. Each student will be responsible for: 1. Analyzing in-depth a major critical issue in biomedical regulatory affairs; 2. Compiling, evaluating, and debating the issue with fellow classmates and faculty; 3. Analyzing material to elaborate the origin of the issue, the evolution and life-cycle, and the application to current practice as a regulatory professional; and, 4. Identifying ways in which their work could be used to assure compliance with existing regulations or effectively leveraged to affect policy making at an industry or government level.
Topical Outline
• Major national and global BioPharma regulatory issues • Key concepts of the BioPharma regulatory policy making process • Stakeholder perspectives and interests • The analytic focus of regulatory policy • Developing a policy topic • The policy paper • Presentation of papers • Debate and critique of papers • Revision of papers • Submission of papers to academic journals and conferences