Course Description

This web seminar provides an overview of the drug development process. Included are the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations and how they interact in the drug development process.

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Learning Objectives

• Describe the FDAEEs role in drug development
• Review the logic behind the drug development process
• Discuss IND/NDA submissions
• Describe the basics of the clinical trial process
• Describe the FDA review process for IND/NDA submissions
• Navigate the three major FDA regulations: GCP, GLP and GMP

Who Should Attend

• Those who want an understanding or greater understanding of the drug development process
• Clinical Research Associates
• Auditors
• Regulatory Affairs Professionals
• Quality Assurance Personnel
• Manufacturing Personnel

Instructor

Elizabeth Ronk Nelson, M.P.H.