An Introduction to FDAs Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products ( (Biotech)
Venue: Online Event
|Event Date/Time: Mar 22, 2011||End Date/Time: Mar 22, 2011|
This presentation will provide participants with an overview of the HCT/P regulations, an understanding of the criteria that FDA uses to determine a productâ€™s regulatory status for marketing and sale; and a discussion of some of the risks associated with commercializing an HCT/P such as a stem cell-based product today.
Understand the criteria that FDA uses to determine a productâ€™s regulatory status (i.e., a biologic, drug or medical device).
Become familiar with the various regulatory options for commercializing a stem cell-based product.
Recognize the potential regulatory risks associated with marketing and selling an HCT/P such as a stem cell-based product.
Exposure to FDAâ€™s regulation of veterinary stem cell therapy.
Areas Covered in the Seminar:
FDAâ€™s legal authority over HCT/Ps including stem cell-based products.
FDAâ€™s regulation HCT/Ps including stem cell-based products.
The criteria FDA uses for determining an HCT/Pâ€™s regulatory status.
The various options for commercializing HCT/Ps including stem cell-based products.
FDAâ€™s recent enforcement action against firms promoting stem cell-based therapies for human use.
An introduction to veterinary stem cell therapy.
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