Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Who Will Benefit from this online training

  • 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

Webinar Takeaway

This 90 minute webinar on FDA regulations of regenerative medicine will cover:

  • How FDA is currently regulating regenerative therapies and products intended for human use in the U.S.
  • The New Drug Application (“NDA”) and the Biologic License Application (“BLA”) review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements. 
  • Preclinical animal and human clinical testing requirements
  • Obtaining designation and approval as Orphan Drug Product.
  • FDA’s regulation of some regenerative medicine products and accessories as Medical Devices.
  • Emergency Use Authorization Designation during the Covid-19 pandemic as it applies to HCT/Ps
  • FDA’s recent enforcement activities.
  • Veterinary regenerative medicine

Training Overview

Regenerative medicine including stem cell therapy focuses on harnessing the power of one’s own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs; and by extension repair injuries and treat disease. In April 2006, the U.S. Food and Drug Administration’s (“FDA”) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Since then the Agency has published Guidance Documents and internal policies interpreting those regulations and describing it proposed methods for implementing them. Among other areas, this includes its oversight of preclinical work and clinical studies. There has also been significant enforcement action in the area as industry seeks to comply with the regulatory requirements and market their products to the public. 

Faculty Karl M. Nobert

Faculty Karl M. Nobert ( 30+yrs. exp.)

Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics, vitamins and dietary supplements, and veterinary products.

He has particular experience in the areas of prescription drugs and regenerative medicine, and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.

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