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

Description

FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering Training is a conference 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
    • Global approval of stem cell technologies
  • Fundamentals of stem cells
    • What is all the excitement about
    • Definitions
    • Sources of stem cells
    • How to control stem cell differentiation
    • Avoiding immune system clearance of stem cells
    • Incorporating stem cells into biomaterials
    • Research examples post-clinical approval
    • Research examples pre-clinical approval
  • Future thoughts on approaches for regulatory approval of stem cell technologies
    • Outlook for new technologies
    • Remaining hurdles
    • Strategies for commercializing stem cell technologies
  • FDA regulatory approvals for the use of stem cells in medicine (continued)
    • The use of human cells, tissues, and cellular and tissue-based product criteria and "Minimal Manipulation Standard"
    • How the FDA regulates regenerative treatments and therapies
    • Regenerative products as medical devices
    • The drug and biological approval process
    • Applicable good manufacturing and good laboratory practices
    • How to design appropriate clinical trials
    • FDA and other federal agency enforcement action
    • Product labeling, marketing and advertising

FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering Training is intended for:

  • 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

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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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