Course Description

This web seminar provides an overview of the regulations and obligations of a sponsor and investigator in the development of a new device using FDA and ICH GCP E6 Guideline — Investigational Device Exemption (IDE) and abbreviated IDE processes. We will begin by reviewing the contents of an IND, and then follow the process of an IND submission. From there, the contents and approval process of an NDA submission will be discussed. This web seminar will also provide a foundation for those who require an understanding of the FDA new drug approval process, and help attendees become familiar with the regulatory landscape in which INDs and NDAs are developed and approved.

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Learning Objectives

• Navigate the FDA approval process for a new drug
• Describe what an IND is, and identify the contents of an IND
• Describe what an NDA is, and identify the contents of an NDA
• Discuss the FDA IND and NDA review process

Who Should Attend

• Regulatory Affairs Personnel
• Quality Assurance Personnel
• Manufacturing Personnel
• Research Personnel
• Those that have to be familiar with the preparation of INDs and NDAs
• Those that have to understand the FDA new drug approval process

Instructor

Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM., P.M.P.

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