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Course Descriptions

Currently accepting applications Apply now >> Next program starts: Autumn 2008 Program location: Bellevue Next information meeting: Tues., Aug. 12 (see details >>) Online info session available now >> (requires Flash Player >>) Sign up to receive e-mail updates >> Contact a program representative >>

Interested in taking a single class? Some courses (designated by a below) may be open on a space-available basis to professionals who are not seeking the certificate. See Single-Course Enrollment for details.

Autumn Course

Introduction to Biomedical Regulatory Affairs

Schedule: Tuesdays, 6:00- 9:00 p.m., Oct. 7 - Dec. 16, 2008 (no class Nov. 11); $1008; 3 CEUs.

Surveys government oversight of drugs, devices and biotechnology derived products; laws and regulations that apply to development, testing and production; and responsibilities of a regulatory affairs specialist in the regulatory setting. Fundamental knowledge that is a prerequisite for the winter and spring courses provided. Topics:

• Overview of the history of U.S. food and drug law, creation of the FDA, and the current organization and responsibilities of the FDA
• Examination of specific U.S. laws and regulations applicable to drugs, devices and biotechnology derived products
• Market clearance requirements and processes, including product classification, clinical studies, GLPs, GCPs, investigational product requirements (IND/IDE), research clearance (IRB)
• Clinical studies design, implementation and monitoring
• Product clearance [NDA/BLA, PMA, 510(k)]
• Roles of a regulatory affairs specialist within an organization and with the FDA

Winter Course

Product Development and Manufacturing Systems

Schedule: Tuesdays, 6-9 p.m., Jan. 13 - Mar. 17, 2009; $1008; 3 CEUs. Visits to local biotechnology-derived therapeutic and medical device manufacturers may be scheduled in the Winter and Spring Quarters. Students will drive and carpool to these sites.

Product development and manufacturing concerns (such as quality control, scale-up, GMPs and quality systems), the FDA inspection process, and FDA regulatory actions are surveyed. Focus on the QSIT (Quality System Inspection Technique). Topics:

• Design and manufacturing product requirements
• Drugs/biologics manufacturing systems requirements including validation
• Device quality system requirements and establishing quality systems
• Device process validation

How to sign up for individual enrollment in this course

Spring Course

Product Testing, Evaluation and Post-Market Issues

Schedule: Tuesdays, 6-9 p.m., Mar. 31 - June 2, 2009; $1008; 3 CEUs. See visit information listed in the second-term course.

Focuses on post-marketing requirements, reporting and enforcement actions. Emphasis on inspection (internal and by regulators) preparation, conduct and follow-up actions. Post-marketing 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, using knowledge gained in the course. Topics:

• Warning letters
• Consent decrees
• Injunctions
• Civil and criminal penalties
• Adverse event reporting
• Corrections, removal and recalls
• Product labeling

How to sign up for individual enrollment in this course

Group Project

A group project running through all three quarters of the program provides an important learning and unifying element. In autumn, student teams select both a medical device and biotechnology-derived therapeutic product of interest. Subsequent assignments are based on these choices. Teams present their work at the end of each term.