Understanding the FDA`s Regulation of HCT/Ps and Successful Product Development Strategies 2017

Topics

• 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

Who should Attend

• 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