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

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

  • FDA regulatory approvals for the use of stem cells in medicine
    • FDA guidance documents for stem cell technologies
    • Currently approved use of stem cells in medicine
    • How the FDA regulates regenerative treatments and therapies
    • Global approval of stem cell technologies
    • The drug and biological approval process
    • The use of human cells, tissues, and cellular and tissue-based product criteria and "Minimal Manipulation Standard"
    • How to design appropriate clinical trials
    • Regenerative products as medical devices
    • Product labeling, marketing and advertising
    • Applicable good manufacturing and good laboratory practices
    • FDA and other federal agency enforcement action
  • Undamentals of stem cells
    • How to control stem cell differentiation
    • What is all the excitement about
    • Incorporating stem cells into biomaterials
    • Sources of stem cells
    • Avoiding immune system clearance of stem cells
  • 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, Tissue Engineering and Gene Therapies brings together:

  • 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

Future Events

FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies 2020

Important

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

Prices are for evaluation only.

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