Event:
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An Introduction to FDA's Regulation of Human Cells
- Hosted By:
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ComplianceOnline
- Start:
- Thursday - Jul 11, 2013 10:00 AM
- End Time:
- Thursday - Jul 11, 2013 11:30 AM
- Location:
- Online
- This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
Why Should You Attend:
This presentation will provide participants with an overview of the HCT/P regulations, an understanding of the criteria that FDA uses to determine a product’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.
Learning Objectives:
- Understand the criteria that FDA uses to determine a product’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 FDA’s regulation of veterinary stem cell therapy.
Areas Covered in the Seminar:
- FDA’s legal authority over HCT/Ps including stem cell-based products.
- FDA’s regulation of HCT/Ps including stem cell-based products.
- FDA’s recent enforcement action against firms promoting stem cell-based therapies for human use.
- An introduction to veterinary stem cell therapy.
- Website:
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