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

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.
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. 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:
Upon completing this course participants should have an understanding of:

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

FDA regulatory approvals for the use of stem cells in medicine

Currently approved use of stem cells in medicine
FDA guidance documents for stem cell technologies
Global approval of stem cell technologies
How the FDA regulates regenerative treatments and therapies
The use of human cells, tissues, and cellular and tissue-based product criteria and “Minimal Manipulation Standard”
The drug and biological approval process
Regenerative products as medical devices
How to design appropriate clinical trials
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

Speaker:
Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.
Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.

For Registration - http://www.complianceonline.com/fda-regulation-regenerative-medicine-stem-cell-tissue-engineering-gene-therapies-seminar-training-80340SEM-prdsm?channel=eventbrite          

Note: Use coupon code REFERRAL10 > and get 10% off on registration.