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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

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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.

Speaker
Instructor: Karl M. Nobert
Product ID: 701927

Why Should You Attend:

Stem cells intended for therapeutic purposes in humans are regulated as biologics under FDA’s April 2006 regulations governing the use of human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) 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 of 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.

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:

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Who Will Benefit:

Instructor Profile:

Karl M. Nobert, is an accomplished attorney with expertise in the U.S. Food and Drug Administration’s regulation of prescription and over-the-counter drug products, food, biologics, medical devices and veterinary products. Mr. Nobert possesses a considerable understanding of and experience dealing with the FDA’s regulation of human and veterinary regenerative medicine including the marketing and sale of stem cell-based products intended for human use. He frequently presents and has published on the subject, and currently services as Legal Advisor to the International Veterinary Regenerative Medicine Society”.

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"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
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