FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering

  • 18-19 July 2019
  • Irvine, CA, United States

FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering is a conference that covers topics such as:

  • FDA regulatory approach for the use of stem cells in medicine
    • FDA guidance documents for stem cell technologies
    • Currently approved/accepted uses of stem cells in medicine
    • How the FDA regulates regenerative treatments and therapies
    • Global approval of stem cell technologies (emphasis on EMA, Japan, China, India and Canada)
    • Use of non-HCT/P therapeutic materials (e.g., PRP and BMC) in the US
    • The use of human cells, tissues, and cellular and tissue-based (HCT/P) products and FDA`s regulatory framework
    • Regenerative products as medical devices
    • The drug and biological approval process
    • Applicable good manufacturing and good laboratory practices
    • How to design appropriate clinical trials with an emphasis on stem cell-based materials
    • FDA and other federal agency enforcement action
    • Product labeling, marketing and advertising
  • Fundamentals of stem cells
    • Sources of stem cells
    • How to control stem cell differentiation
    • Avoiding immune system clearance of stem cells
    • Incorporating stem cells into biomaterials
  • Future thoughts on approaches for regulatory approval of stem cell technologies
    • Outlook for new technologies
    • Remaining hurdles

FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering brings together senior attendees involved or interested in:

  • Quality professionals
  • Senior quality managers
  • Compliance professionals
  • Regulatory professionals
  • Manufacturing engineers
  • Production supervisors
  • Design engineers
  • Production engineers
  • Contract manufacturers
  • Labelers and private labelers
  • U.S. agents of foreign corporations
  • Importers and custom agents
  • Quality engineers
  • Process owners
  • Document control specialists
  • Quality auditors
  • Medical affairs
  • Record retention specialists
  • Financial advisors and institutional investors
  • Legal professionals
  • Graduate students
  • Patent lawyers
  • Clinicians
  • Academic faculty and professors
  • Entrepreneurs

FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering will be held in Irvine, CA, United States on 18-19 July 2019.

Venue

Irvine,
California,
United States
  View all Hotels near Venue
Booking.com
1899-2099 US Dollar
No exhibition
ComplianceOnline
Rentalcars Savings

Future Events

  • FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering - 18-19 Jul 2019, Irvine, CA, United States (85154)

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.