Understanding the FDA's Regulation of HCT/Ps and Successful Product Development Strategies (com)

Thu Feb 1
San Francisco
08:30 AM
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In 1997, the FDA proposed a comprehensive regulatory program for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/Ps) outlining the registration and listing procedures for HCT/Ps. This program also differentiates between HCT/Ps that will be regulated via the traditional pathway and those that will undergo approval as new drugs, biologics or devices.
In this seminar, we'll discuss the historical context for the use of HCT/Ps in medicine as well as how the HCT/P market is evolving. You will be shown examples of the FDA-approved use of HCT/Ps and what is required for successful product development. This course will also provide an overview of the health authority regulating HCT/Ps, discuss the regulations that govern HCT/Ps, discuss potential product development strategies and provide an overview of product development in the United States.

Learning Objectives:
Upon completing this course, participants will better understand:

The FDA’s regulatory approval process for HCT/Ps
Keys to successful product development of HCT/Ps
Application of “Minimal Manipulation,” “Homologous Use” and “Chemical Action”
Currently approved use of HCT/Ps in medicine
The drug and biologic approval process
Nonclinical requirements to support product development

Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Challenges of product characterization and specifications with respect to HCT/Ps
Requirements for compliance with good tissue practice, good manufacturing practice and good laboratory practice
FDA enforcement actions
The global regenerative medicine market
The One Health Initiative and its impact
HCT/Ps and translational medicine
Future approaches for regulatory approval of HCT/Ps in regenerative medicine

Who will Benefit:
This course is designed for professionals in biotechnology, regenerative medicine, HCT/P, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

Graduate students
Academic faculty and professors
Regulatory professionals
Compliance professionals
Manufacturing professionals
Quality Control professionals
Contract manufacturers
Foreign corporations in the regenerative medicine field
Financial advisors and institutional investors

DAY 01(8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
FDA regulatory oversight of HCT/Ps

Historical Perspective
Laws and Regulations

Tissue Reference Group
Office of Combination Products

Request for Designation

FDA regulatory approval process

HCT/Ps as drugs/biologics
HCT/Ps as medical devices


Good tissue practice
Good manufacturing practice
Quality system regulations
Good laboratory practice
FDA enforcement actions
Adverse event reporting

DAY 02(8:30 AM - 4:30 PM)

FDA regulatory guidance regarding HCT/Ps

Minimal manipulation
Homologous use
Same surgical procedure
Adipose tissue

Overview of FDA Public Workshop on Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval

Product development
FDA viewpoint
Views from professional societies
Patient experiences

Overview of FDA Part 15 Hearing on Draft Guidance Relating to the Regulation of HCT/Ps

Industry perspective
Professional society perspective
Patient perspective
HCT/Ps and translation medicine
One Health Initiative

Approaches for regulatory approval of HCT/Ps in regenerative medicine

FDA expedited review programs
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Gwen Wise-BlackmanPrincipal Consultant, Gwen Wise-Blackman Consulting, LLC

Gwen Wise-Blackman, Ph.D., has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals. She is currently Principal Consultant at Gwen Wise-Blackman Consulting. Her career focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.

Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for: - Discounts for multiple participants.- Require a price quotation.- Require to pay by wire transfer or PayPal- Invitation letter for visa applicationsNO REFUNDS ALLOWED ON REGISTRATIONS -----------------------------------------------------------------This Event is Brought to You by: METRICSTREAM INC - NewYorkEventsListhttp://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.comMYL171013CEV


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