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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

Instructor: Karl M. Nobert
Product ID: 701927
  • Duration: 90 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2013

Training CD / USB Drive

$299.00
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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:

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:

  • 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.
  • The criteria FDA uses for determining an HCT/P’s regulatory status.
  • The various options for commercializing 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.

Who Will Benefit:

  • Individuals who work in the Regulatory Affairs departments of pharmaceutical, biotech & 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

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”.

Follow us :
Upcoming In-person Seminars by EX-FDA OFFICIALS
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments

Refund Policy

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 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. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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