2-Hour Virtual Seminar
2 Hours Virtual Seminar on An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use
Webinar ID: 501293
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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.
This presentation will provide participants with an overview of the HCT/P regulations, an understanding of the criteria that the 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 stem cell-based product today.
Why should you Attend:
Areas Covered in the Session:
- Stem cells intended for therapeutic purposes in humans are regulated as biologics under the FDA's April 2006 regulations governing the use of human cells, tissues, and cellular and tissue-based products ("HCT/") in humans. These regulations define HCT/Ps as "articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient."
- Among other things, the regulations include provisions governing registration and listing requirements for establishments that manufacture and process HCT/Ps; provisions discussing donor eligibility; recommended current good tissue practices covering all stages of production, including harvesting, processing, manufacture, storage, labeling, packaging, and distribution; and other requirements intended to prevent the introduction, transmission, and spread of communicable diseases in humans.
- An HCT/P is not automatically treated as a drug product by FDA. Instead, a drug v. non-drug distinction is made between HCT/Ps on the basis of an applied "minimal manipulation" standard and other identifiable criteria. Thus, depending on the amount of manipulation involved in the production process, a product's satisfaction with the FDA's other regulatory criteria, and consideration of a product's ultimate intended use, HCT/Ps (including stem cell-containing products) can be regulated as simply licensed biologics or products requiring Agency review and approval as new drugs.
Who Will Benefit:
- 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 the FDA's regulation of veterinary stem cell therapy.
- Individuals who work in the Regulatory Affairs departments of pharmaceutical, biotech, and biologics companies
- Quality Assurance
- In-house counsel, lawyers who work for or represent pharmaceutical and biotech companies, and other legal staffers interested in the development and commercialization of HCT/Ps such as stem cell-based products
- Financial analysts specializing in and investors watching the pharmaceutical, life sciences, and biotech industries
- Policy makers responsible for creating laws governing the use of stem cells
Karl Nobert , FDA Regulatory Attorney, Michael Best & Friedrich LLP. Karl focuses his practice on FDA Regulatory law, representing the U.S. and international clients in food.
and drug industries with regard to pharmaceuticals and biologics, medical devices, and veterinary products. He has particular experience and professional interest in the areas of prescription drugs, regenerative medicine, and animal health. In addition to practicing law, Karl founded a veterinary drug company that is pursuing approval for an equine cell-based respiratory drug.