FDAnews Announces — HCT/P: FDA’s Newest Regulatory Battleground Webinar, Feb. 25, 2015

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On Dec. 22 and 23 the FDA released two important guidances regarding the management of human cells, tissues and cellular/tissue based products (HCT/P). Join FDAnews on Feb. 25 for an exclusive analysis of the FDA oversight of HCT/Ps with a focus on what the draft guidelines mean to manufacturers.

HCT/P: FDA’s Newest Regulatory Battleground
How FDA’s Tissue Guidances Will Impact Manufacturers and Users
**FDAnews Webinar**
Feb. 25, 2015 — 1:30 a.m. – 3:00 p.m. EST
http://www.fdanews.com/HCTPRegBattleground

Join FDAnews on Feb. 25 for an exclusive analysis of the FDA oversight of HCT/Ps with a focus on what the draft guidelines mean to manufacturers.

On Dec. 22 and 23 the FDA released two important guidances regarding the management of human cells, tissues and cellular/tissue based products (HCT/P). The guidances were:

  •     Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products -Draft Guidance
  •     Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations-Draft Guidance

Two small words “minimal manipulation” are raising serious – potentially enormous — concerns for manufacturers, affiliated companies, healthcare providers, research organizations, physicians and others involved in regenerative sciences.

Depending on how HCT/Ps are managed drug and device manufacturers now may fall under FDA’s direct regulatory oversight. If so, these draft guidances will require them, for the first time, to potentially file new drug or device applications, conduct clinical trials, comply with cGMP and QSR regulations and applicable post market surveillance requirements.

While these guidances were welcomed by HCT/P manufacturers, affiliated companies, healthcare providers, research organizations and physicians, for some these guidances will dramatically impact their operations and finances.

Attendees will leave the event understanding:

  •     The FDA’s position on when a HCT/P constitutes a drug/device and what resulting requirements need to be fulfilled
  •     How the courts have interpreted “minimal manipulation” and how manufacturers may be in violation given their existing processes
  •     What processes in the draft guidances constitute some of the acceptable forms of minimal manipulation (i.e. rinsing, cleaning (or cleansing), sizing, shaping)
  •     What processes (aka manufacturing steps) previously found to be acceptable meet the new standard of minimal manipulation; what’s in and what’s out?
  •     How manufacturers can influence the draft guidances and what possible areas of the guidances the FDA will revise.
  •     What the regenerative sciences decision means for the rapidly growing field of adipose tissue

Meet the Presenter:
Dr. Stacie Ropka, Counsel for Axinn, Veltrop & Harkrider LLP, holds a PhD in Microbiology and Immunology. Her practice is focused on IP litigation, due diligence and client counseling with an emphasis on the life sciences, biologics and biologic-based pharmaceuticals. Stacie keeps abreast of the technology and related law by regularly attending both scientific and legal conferences. Prior to attending law school, Stacie held a faculty position at SUNY Upstate Medical University. She also spent many years as a research scientist in the fields of neurology, virology and immunology, both at Northwestern University and SUNY Upstate Medical University, and has presented her original research at numerous scientific conferences.

Who Will Benefit:

  •     Regulatory affairs professionals
  •     Medical affairs professionals
  •     Product Lifecycle Management professionals
  •     Compliance personnel
  •     QA/QC personnel
  •     Senior management
  •     In-house and outside counsel
  •     Professionals new to HCT/Ps

Conference Details:
HCT/P: FDA’s Newest Regulatory Battleground
How FDA’s Tissue Guidances Will Impact Manufacturers and Users
**FDAnews Webinar**
Feb. 25, 2015 — 1:30 a.m. – 3:00 p.m. EST
http://www.fdanews.com/HCTPRegBattleground

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/HCTPRegBattleground
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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Michelle Butler
FDANEWS
+1 (703) 538-7665
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