FDA's Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering

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