2 Day Seminar: FDA's Regulation of Regenerative Medicine including: Stem Cell Treatments / Tissue Engineering / Gene Therapies (San Francisco, CA - June 28-29, 2018) - ResearchAndMarkets.com

Published: Apr 13, 2018

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 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.

Currently, there is an ongoing debate in industry on how such therapies should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

Learning Objectives

  • Fundamentals of stem cells
  • What is all the excitement about
  • How to control stem cell differentiation
  • Sources of stem cells
  • Incorporating stem cells into biomaterials
  • Avoiding immune system clearance of stem cells

Agenda

Day One (8:30 AM - 4:30 PM)

8:30 AM - 9:00 AM: Registration Process

9:00 AM: Session Start

A. Fundamentals of stem cells

a. Definitions

b. What is all the excitement about

c. How to control stem cell differentiation

d. Sources of stem cells

e. Incorporating stem cells into biomaterials

f. Avoiding immune system clearance of stem cells

g. Research examples pre-clinical approval

h. Research examples post-clinical approval

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

a. Currently approved use of stem cells in medicine

b. FDA guidance documents for stem cell technologies

c. Global approval of stem cell technologies

Day Two (8:30 AM - 4.30 PM)

C. FDA regulatory approvals for the use of stem cells in medicine (continued)

a. How the FDA regulates regenerative treatments and therapies

b. The use of human cells, tissues, and cellular and tissue-based product criteria and Minimal Manipulation Standard

c. The drug and biological approval process

d. Regenerative products as medical devices

e. How to design appropriate clinical trials

f. Applicable good manufacturing and good laboratory practices

g. Product labeling, marketing and advertising

h. FDA and other federal agency enforcement action

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

a. Remaining hurdles

b. Outlook for new technologies

c. Strategies for commercializing stem cell technologies

E. Questions

For more information about this conference visit https://www.researchandmarkets.com/research/t8pp4d/2_day_seminar?w=4

 

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