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FDAnews Announces -- Regenerative Medicine and Stem Cell Regulation: What You Need to Know Webinar, Sept. 17, 2019


FALLS CHURCH, Va., Sept. 3, 2019 /PRNewswire-PRWeb/ -- Regenerative Medicine and Stem Cell Regulation
What You Need to Know
An FDAnews Webinar
Tuesday, Sept. 17, 2019, 1:30-3:00 p.m. EDT

Confused about the FDA's regenerative medicine and stem cell therapies regulations?

This webinar will explain 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. Dr. Blumenfeld will explain the latest on the FDA's interpretation of its stem cell regulatory framework, and how it has recently enforced that interpretation, including:

  •     The FDA regulatory framework in 21 C.F.R. Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps)
  •     How to distinguish between HCT/Ps that are exempt from FDA regulations, only subject to certain FDA regulations (361 HCT/Ps) or require full FDA pre-approval prior to marketing (351 HCT/Ps)
  •     FDA's November 2017 regenerative medicine framework, including new and revised guidance documents
  •     Enforcement efforts that FDA has taken since November 2017, including the issuance of warning letters and industry letters and relevant court actions
  •     FDA's recent victory in the U.S. Stem Cell case in Florida, and what it means for companies and physicians moving forward
  •     FTC's October 2018 settlement with Regenerative Medical Group and Telehealth Medical Group (California) for false and misleading consumer advertising
  •     The New York State Attorney General's case against Park Avenue Stem Cell (New York)
  •     Various opportunities for the legal development and use of stem cells

FDA's enforcement actions have been ramping up. You must begin preparing now… start with this webinar!

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Regenerative Medicine and Stem Cell Regulation
What You Need to Know
An FDAnews Webinar
Tuesday, Sept. 17, 2019, 1:30-3:00 p.m. EDT

$287 per site

Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.



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