Courses & Degree Requirements

Instructors: Joshua Kim
Credits: 3
This course covers product development and manufacturing concerns, such as quality control, scale-up, good manufacturing practices. It also covers quality systems and the U.S. Food and Drug Administration inspection process and FDA regulatory actions. The focus is on the Quality System Inspection Technique, known as QSIT. 

Instructors: David Hammond and Mary Lessig
Credits: 3
This course introduces the major concepts underlying how clinical trials are designed and run. It focuses on the phases of clinical trials, the role of the U.S. Food and Drug Administration, institutional review boards, the Code of Federal Regulations and ethical principles. Clinical study design and statistical concepts are also addressed.

Instructor: Brent Lewis
Credits: 2
This course covers the essential skills needed in regulatory affairs and includes an overview of local medical products companies.

Instructors: Joshua Kim
Credits: 3
This course focuses on post-market requirements, reporting and enforcement actions. Emphasis is placed on inspection (internal and by regulators), preparation, conduct and follow-up actions. Post-market surveillance and studies and reimbursement and economics of pharmacology are discussed. As a final class project, students work in teams to design a regulatory strategy for a product. 

Instructors: David Hammond and Mary Lessig
Credits: 3
This course addresses the business dimension of clinical trials. It covers the principles of project management, planning, analysis, contingency and follow-up within the context of clinical trials that involve a large number of tasks and people responsible for parts of the overall study. 

Instructor: Lori Martell
Credits: 2
This course further examines communications with attention to best writing practices. It provides an intensive review of common editing standards and advanced strategies for crafting accurate and effective documentation. Credit/no credit only. 

Instructor: Ali Bouge
Credits: 9
This course provides a practical experience to ensure that participants can shepherd new medical products — drugs, devices and biologics — through regulatory, clinical and quality assurance processes. Students work on projects of their choice under the guidance of a preceptor at the practicum site. Each student plans a project with input from the preceptor, implements the plan and presents a final written report and oral presentation. Coordination and academic oversight is provided by the practicum director. Credit/no credit only.

This is an independent study course, with no required class sessions. The nine credits will be earned across a minimum of two quarters, with the pace of activities dependent the individual student and project.

Instructor: David Hammond
Credits: 3
This course develops an understanding of international differences in the regulation of design, manufacture, and post-marketing surveillance of medical products relative to U.S. Food and Drug Administration requirements. 

Instructor: Jessica Urban
Credits: 3
This course teaches the principles and applications of risk management methods in the design, manufacturing and marketing of medical products. 

Instructor: Ali Bouge
Credits: 9
This course provides a practical experience to ensure that participants can shepherd new medical products — drugs, devices and biologics — through regulatory, clinical and quality assurance processes. Students work on projects of their choice under the guidance of a preceptor at the practicum site. Each student plans a project with input from the preceptor, implements the plan and presents a final written report and oral presentation. Coordination and academic oversight is provided by the practicum director. Credit/no credit only.

This is an independent study course, with no required class sessions. The nine credits will be earned across a minimum of two quarters, with the pace of activities dependent the individual student and project.

Instructor: Aasthaa Bansal and Andy Stergachis
Credits: 3
This course applies statistical techniques to meet medical product regulatory commitments including biosimilars, product comparability, design and continued process verification. Prerequisite: Introductory statistics. 

Instructor: Ali Bouge
Credits: 9
This course provides a practical experience to ensure that participants can shepherd new medical products — drugs, devices and biologics — through regulatory, clinical and quality assurance processes. Students work on projects of their choice under the guidance of a preceptor at the practicum site. Each student plans a project with input from the preceptor, implements the plan and presents a final written report and oral presentation. Coordination and academic oversight is provided by the practicum director. Credit/no credit only.

This is an independent study course, with no required class sessions. The nine credits will be earned across a minimum of two quarters, with the pace of activities dependent the individual student and project.

Instructor: David Hammond
Credits: 2
This course provides an in-depth exploration of current regulatory issues related to medical product development. 

Instructor: Ali Bouge
Credits: 9
This course provides a practical experience to ensure that participants can shepherd new medical products — drugs, devices and biologics — through regulatory, clinical and quality assurance processes. Students work on projects of their choice under the guidance of a preceptor at the practicum site. Each student plans a project with input from the preceptor, implements the plan and presents a final written report and oral presentation. Coordination and academic oversight is provided by the practicum director. Credit/no credit only.

This is an independent study course, with no required class sessions. The nine credits will be earned across a minimum of two quarters, with the pace of activities dependent the individual student and project.