$2,089 – $8,289

Understanding the FDA's Regulation of HCT/Ps and Successful Product Develop...

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Irvine, CA

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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
  • 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
  • Clinicians
  • Entrepreneurs
  • 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
    • Definitions
    • Jurisdiction
      • Tissue Reference Group
      • Office of Combination Products
        • Request for Designation
  • FDA regulatory approval process
    • HCT/Ps as drugs/biologics
    • HCT/Ps as medical devices
  • Compliance
    • 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

Debra Webster

Debra Webster,
Principal Scientist, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences | Ex-FDA Professional (Reviewing Pharmacologist)

Debra Webster, PhD, is Principal Scientist, Regulatory Affairs and Product Development, for Cardinal Health Regulatory Sciences. She began her regulatory career at the FDA and has more than 25 years of experience in drug development, focusing on nonclinical toxicology and proof-of-concept. Dr. Webster is responsible for nonclinical and regulatory consulting to guide products from pre-Investigational New Drug (pre-IND) application interactions with the FDA to New Drug Application (NDA) and Biological License Application (BLA) approval.

Prior to joining Cardinal Health, Dr. Webster was a medical writer at Quintiles, where she authored clinical study reports and nonclinical sections of INDs. Previously, she was in private practice, where she authored summaries of nonclinical data to support due diligence and regulatory submissions. Dr. Webster worked for the FDA in the Center for Food Safety and Nutrition, where she evaluated color and food additive petitions. Subsequently, she was a pharmacology/toxicology reviewer in the FDA Division of Antiviral Drugs in the Center for Drug Evaluation and Research, where she received the Commissioner Frank E Young Appreciation recognition for her role in the approval of Foscarnet.

Dr. Webster received a doctorate degree in pharmacology and toxicology at Virginia Commonwealth University, Medical College of Virginia. She received a bachelor’s degree in biology from Virginia Polytechnic and State University, where she graduated with honors and worked as a research associate in the anaerobic microbiology laboratory.

David A. Cummings

David A. Cummings,
RAC, Director, Scientific and Regulatory Consulting

David A. Cummings is Director, Chemistry, Manufacturing and Controls (CMC), for Cardinal Health Regulatory Sciences. He is responsible for scientific and regulatory consulting activities associated with pharmaceutical and biological product development, regulatory affairs strategy development, participation in FDA meetings, preparation of investigational and marketing applications for small molecules and biologics, good manufacturing practice qualification audits and good laboratory practice audits.

Cummings has more than 24 years of experience with development and regulatory affairs of small molecule and biologic products. His biologic experience includes viral antigens, enzymes, monoclonal antibodies, gene therapy products and therapeutic proteins. Prior to joining Cardinal Health in 2008, Cummings worked in several product development and regulatory affairs roles with Chiron Corporation, Gen-Probe, Collateral Therapeutics and Peregrine Pharmaceuticals.

Cummings received a bachelor’s degree in molecular, cellular and developmental biology from the University of Colorado and worked in the laboratory of Dr. Richard G. Ham. Cummings received regulatory affairs certification (RAC) in 2001.

Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

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