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Introduction to Clinical Research: Clinical Trial Phases and Design

X400.2 (3 semester unit in Public Health)

Review the drug development process, the principles of good clinical practice, the clinical trial phases and design, the principal players in clinical research, and regulatory strategies for developing medical devices, and medical terminology.

There are currently no sections open for enrollment.

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Sections closed for enrollment

Tues. Oct. 27, Online

MICHAEL DUBINSKY, B.S., worked for 24 years with the FDA. He was the deputy director, Office of Compliance, CBER when he left the FDA in 1998. From 1998 through 2006, Dubinsky held senior-level positions in regulatory affairs, quality assurance, development quality assurance and compliance. He currently consults on GCP compliance and quality topics.

KAREN HENRY, M.P.H., is a clinical research consultant and has worked for 20 years in industry and academic health institutions in the areas of Good Clinical Practice principles and regulations, clinical trials management, standard operating procedures development and management, and clinical quality compliance.

NOTE: This class is closed. For information about related courses, contact your academic department.

• Online course: Internet access required
• Oct. 27 to Dec. 21
• $1,895 (EDP 841577)

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