HCT/P: FDA’s Newest Regulatory Battleground - Webinar CD/Transcript

Quantity Discounts
1 - 2
3 - 4
5 - 6
7 - 9
10 - 9999

HCT/P: FDA’s Newest Regulatory Battleground – How FDA’s Tissue Guidances Will Impact Manufacturers and Users

Get an exclusive analysis of the FDA oversight of HCT/Ps with a focus on what the draft guidelines mean to you.

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  • Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products -Draft Guidance
  • Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations-Draft Guidance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

Are you now under the FDA’s direct regulation?

Depending on how you manage HCT/Ps you now may fall under FDA’s direct regulatory oversight.  If so, these draft guidances will require you – 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.

Learning Objectives

This presentation will teach you:

  • 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 you 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 you 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

If you’re involved in HCT/Ps, regenerative sciences or support this industry, you must attend this upcoming webinar! Particularly:

  • 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

Dr. Stacie Ropka, Of 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. Stacie is a member of the American Bar Association, The American Society for Microbiology and The Antibody Society.