HCT/P: FDA’s Newest Regulatory Battleground

Date	Feb 25, 2015
Time	01:30 PM EDT
Cost	$287.00
Online

oin us on February 25 for an exclusive analysis of the FDA oversight of HCT/Ps with a focus on what the draft guidelines mean to you.

Why You Should Attend:

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•     Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products -Draft Guidance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  Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations-Draft Guidance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

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

Easy Ways to Register:
Online:      www.fdanews.com/HCTPRegBattleground
By phone: 888-838-5578 or 703-538-7600