FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies 2017 is a seminar 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
- How the FDA regulates regenerative treatments and therapies
- Global approval of stem cell technologies
- The drug and biological approval process
- The use of human cells, tissues, and cellular and tissue-based product criteria and "Minimal Manipulation Standard"
- How to design appropriate clinical trials
- Regenerative products as medical devices
- Product labeling, marketing and advertising
- Applicable good manufacturing and good laboratory practices
- FDA and other federal agency enforcement action
- Undamentals of stem cells
- How to control stem cell differentiation
- What is all the excitement about
- Incorporating stem cells into biomaterials
- Sources of stem cells
- Avoiding immune system clearance of stem cells
- 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, Tissue Engineering and Gene Therapies 2017 brings together:
- 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
