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  • An Introduction to FDA's Regulation of Human Cells

  • Hosted By:
  • 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.
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