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