FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies (Burlingame CA, United States - June 28-29, 2018) - ResearchAndMarkets.com

DUBLIN--()--The "FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies" conference has been added to ResearchAndMarkets.com's offering.

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 startup 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.

This tutorial 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 the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue based products.

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

Agenda:

1. Fundamentals of stem cells

2. FDA regulatory approvals for the use of stem cells in medicine

3. Future thoughts on approaches for regulatory approval of stem cell technologies

4. Questions

For more information about this conference visit https://www.researchandmarkets.com/research/hkbtg5/fdas_regulation?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Biopharmaceuticals , Stem Cells , Biomaterials

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Biopharmaceuticals , Stem Cells , Biomaterials