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

  • 22-23 Oct 2020
  • Online Event

Description

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

FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering Training will be held on 22-23 Oct 2020.

More Details

Prices:
1899 US Dollar   (Early registration date: 26 Sep 2020)
Exhibition:
No exhibition
Organizer:
World Compliance Seminars (WCS)
Website:

Future Events

  • FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering Training - 22-23 Oct 2020 (85154)
  • FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering Training 2021

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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