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

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

Future Events

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