Understanding the FDA`s Regulation of HCT/Ps and Successful Product Development Strategies

Understanding the FDA`s Regulation of HCT/Ps and Successful Product Development Strategies is a seminar that covers topics such as:

  • Keys to successful product development of HCT/Ps
  • The FDA’s regulatory approval process for HCT/Ps
  • Currently approved use of HCT/Ps in medicine
  • Application of "Minimal Manipulation," "Homologous Use" and "Chemical Action"
  • Nonclinical requirements to support product development
  • The drug and biologic approval process
  • Lunch
  • Seminar Fee Includes:
  • Seminar Material
  • AM-PM Tea/Coffee
  • Hard copy of presentation
  • USB with seminar presentation
  • $100 Gift Cert for next seminar
  • Attendance Certificate
  • Requirements for compliance with good tissue practice, good manufacturing practice and good laboratory practice
  • Challenges of product characterization and specifications with respect to HCT/Ps
  • The global regenerative medicine market
  • FDA enforcement actions
  • HCT/Ps and translational medicine
  • The One Health Initiative and its impact
  • Future approaches for regulatory approval of HCT/Ps in regenerative medicine

Understanding the FDA`s Regulation of HCT/Ps and Successful Product Development Strategies brings together:

  • Academic faculty and professors
  • Graduate students
  • Entrepreneurs
  • Clinicians
  • Compliance professionals
  • Regulatory professionals
  • Quality Control professionals
  • Manufacturing professionals
  • Foreign corporations in the regenerative medicine field
  • Contract manufacturers
  • Financial advisors and institutional investors

Future Events

Understanding the FDA`s Regulation of HCT/Ps and Successful Product Development Strategies 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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