This webinar will discuss the FDA rules and regulations regarding the potential of using live cells in medicine. It will cover FDA guidance documents for cellular and gene therapy and major differences between the rules in the USA and other countries.
This webinar will address the issues with regard to the potential of using live cells in medicine and major rules by FDA and other controlling organizations regulating this important field.
Why Should You Attend:
Cellular therapy is a term used in both medicine and cosmetic products. It is a fast developing and extremely promising field (especially stem cell therapy and human organ bio-fabrication), attracting a great deal of attention from physicians, investors and manufacturers alike. Yet most people are not aware that in the US there are some strong federal rules restricting the use of this emerging technology. In February 2009, the FDA issued its document “Compliance Program Guidance Manual” regulating the use of human cell lines and tissues. There were some additions to the document since that time. Also, there are some special regulations approved by certain states.This webinar will address the issues with regard to the potential of using live cells in medicine and major rules by FDA and other controlling organizations regulating this important field.
Areas Covered in the Webinar:
- How human cells are used in medicine and industry now and what are the anticipated changes for the future.
- Rules for handling such objects in cellular and gene therapy; major differences between the rules in the USA and other countries.
- FDA guidance documents for cellular and gene therapy (from 1997 to 2014).
- Human cells and cell lines regulated by CDRH and by CBER. What is the difference?
- PHS Act section 361 and section 351 products.
- FDA and regulatory issues surrounding personalized medicine.
- Can stem cells be regulated as drugs? - Court appeals decision on 4 February 2014.
- Flat and 3D cellular models - pro and contra; 3D live cell printing for human organs.
- Robotic systems available for handling human cells and cell lines for cellular therapy and new drug screening assays.
- Business forecast for the future.
- Ethical and regulatory debates around bio-printing.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in new and emerging companies operating in the field of live cell therapy and bioprinting. The following titles will benefit:- Regulatory professionals
- Compliance professionals
- Production supervisors
- Manufacturing engineers
- Production engineers
- Design engineers
- Labelers and Private Labelers
- Contract manufacturers
- Quality engineers
- Quality auditors
- Investors looking for a winning company in the field
- Healthcare providers interested to learn about perspectives of patient-oriented methods of live-cells handling and organ bioprinting
Course Provider
Igor Zlatkin,
