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Program Overview

The 2008-2009 program is underway and is no longer accepting applications Single courses may be available » Next program starts: Autumn 2009 Details will be posted in spring Program location: Bellevue Sign up to receive e-mail updates >> Contact a program representative >>

This nine-month program is designed for individuals seeking an introductory or expanded understanding of regulatory affairs for the drug and medical device industry, and for others seeking training for positions in the field. Program participants gain a comprehensive overview of the knowledge and skills necessary to be an effective regulatory affairs and compliance specialist. Such specialists oversee the design, development testing and production of drugs, biotechnology-derived therapeutics, or medical devices.

Specific learning objectives include:

• An understanding of the roles and responsibilities of a regulatory affairs specialist
• An understanding of the organization and regulatory jurisdiction of the U.S. Food and Drug Administration
• Knowledge of the distinctions and similarities among the drug, biotechnology-derived therapeutic product, and device classifications
• A working knowledge of U.S. laws applicable to drugs, devices and biotherapeutics
• A working knowledge of the product approval process, Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), Good Manufacturing Practices (GMPs), FDA inspection process and post-market issues
• An understanding of general business, legal, and scientific concepts related to pre-clinical and clinical trials
• Familiarity with legal concerns relating to intellectual property, patents, technology transfer, clinical trials and product liability
• An understanding of the dynamic nature of the regulatory environment
• Exposure to professional perspectives and networking opportunities through presentations by guest experts in the field
• An ability to locate regulatory information in key national and international sources

Related Programs

• Clinical Trials
• Healthcare Regulatory Affairs
• Intellectual Property Management
• Medical Devices and Commercialization
• Master of Science in Biomedical Regulatory Affairs

Contact a Program Representative

If you have questions about this program, please call 206-685-8936 in the greater Seattle area, or 888-469-6499, or e-mail us.