This course provides an overview of combination products, including relevant definitions, scientific principles, and the regulatory landscape. In this course, we will look at which FDA centers are involved in the review of combination products. Specific attention will be paid to the FDA Office of Combination Products, including submissions and how the Office of Combination Products makes their determinations. Participants will gain knowledge about the combination products process and the underlying scientific and regulatory principles involved.
- Define combination products
- Discuss the role and process of the Office of Combination Products
- Describe combination products’ submissions
- Discuss how the Office of Combination Products makes its determinations
This course is intended for Regulatory, Quality, Clinical, Research, Manufacturing, Legal, and other personnel who require a general understanding of the combination product process.
Albert A. Ghignone, M.S., R.A.C.
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3 hours; 12:30 - 3:30 p.m. Eastern
October 22, 2010
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.