FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies 2017

Topics

• 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

Who should Attend

• 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