This Seminar will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. It will also provide few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. Learn the fundamentals of stem cells and FDA’s regulatory approach for its use in medicine.
Stem cells harness the power to differentiate into numerous cells upon stimulation. This has led to their wide exploration across all of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications. Attend this seminar to learn and apply the definitive ways to needed for the field to progress.
Learning Objectives:
Upon completing this course participants should have an understanding of:
- Fundamentals of stem cells
- How to control stem cell differentiation
- Sources of stem cells
- Incorporating stem cells into biomaterials
- Avoiding immune system clearance of stem cells
- FDA regulatory approach for the use of stem cells in medicine
- Currently approved/accepted uses of stem cells in medicine
- FDA guidance documents for stem cell technologies
- Global approval of stem cell technologies (emphasis on EMA, Japan, China, India and Canada)
- How the FDA regulates regenerative treatments and therapies
- The use of human cells, tissues, and cellular and tissue-based (HCT/P) products and FDA’s regulatory framework
- Use of non-HCT/P therapeutic materials (e.g., PRP and BMC) in the US
- The drug and biological approval process
- Regenerative products as medical devices
- How to design appropriate clinical trials with an emphasis on stem cell-based materials
- Applicable good manufacturing and good laboratory practices
- Product labeling, marketing and advertising
- FDA and other federal agency enforcement action
- Future thoughts on approaches for regulatory approval of stem cell technologies
- Remaining hurdles
- Outlook for new technologies
Who will Benefit:
This course is designed for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Manufacturing engineers
- Production engineers
- Design engineers
- Labelers and private labelers
- Contract manufacturers
- Importers and custom agents
- U.S. agents of foreign corporations
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
- Record retention specialists
- Medical affairs
- Legal professionals
- Financial advisors and institutional investors
- Patent lawyers
- Graduate students
- Academic faculty and professors
- Clinicians
- Entrepreneurs
For Registration :
Note: Use coupon code < REFERRAL10 > and get 10% off on registration.