Course Description

This web seminar provides an overview of the drug development process and how the FDA approves new drugs. The Investigative New Drug (IND) contents and the New Drug Application (NDA) are described with reference to applicable FDA regulations and the phases of clinical trials required by the FDA.

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Learning Objectives

• Describe the FDA’s role in drug development
• Describe the basics of the clinical trial process
• Describe the FDA review process for IND/NDA submissions

Who Should Attend

• Clinical Research Coordinators
• Clinical Research Associates
• Clinical Trial Managers
• Clinical Project Managers
• Regulatory Affairs Personnel
• Quality Assurance Personnel
• Manufacturing Personnel
• Research Personnel
• Personnel that have to understand the FDA new drug approval process

Instructor

Lily Romero, P.A., C.C.R.C.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.