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Regenerative Medicine and Stem Cell Regulation: What You Need to Know
If you find the FDA’s regulatory framework regarding regenerative medicine and stem cell therapies confusing, you’re not alone. A noted expert is here to explain the current regulatory framework and FDA’s interpretation, enforcement actions not only from FDA but FTC and the states, and opportunities for the legal development and use of stem cells.
You’ll gain an understanding of the FDA’s regulations and enforcement, and how stem cell stakeholders (pharma/biotech companies, healthcare providers) can best comply.
As a lawyer with a Ph.D. in molecular biology and an M.A. in biomedical ethics, Barbara A. Binzak Blumenfeld, Ph.D. is uniquely qualified to address how the law and stem cell science converge. A shareholder in the FDA & Biotechnology practice group at Buchanan Ingersoll & Rooney PC’s Washington DC office, Dr. Blumenfeld will explain the latest on FDA’s interpretation of its stem cell regulatory framework, including its recent enforcement of that interpretation.
FDA’s enforcement actions have been ramping up. You must begin preparing now… start with this presentation!
Barbara A. Binzak Blumenfeld, Ph.D. is a shareholder in the FDA & Biotechnology practice group at Buchanan Ingersoll & Rooney PC’s Washington DC office. She holds a law degree and an M.A. in biomedical ethics from Case Western Reserve University and a Ph.D. in molecular biology from the Mayo Graduate School. Dr. Blumenfeld’s unique educational background allows her to understand stem cell science and to apply the law to that science. She has advised stem cell clients in various capacities, including pre-IND meetings and IND submissions, advertising and promotion matters, investment funding deals and international inspection issues. Dr. Blumenfeld has also spoken and written about regenerative medicine and stem cell issues for several years, including for the Food and Drug Law Institute and Phaciliate Leaders World/the World Stem Cell Summit.
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