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

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This course is designed for professionals in biotechnology, regenerative medicine, HCT/P, pharmaceutical and animal drug companies, veterinary hospitals and clinics.

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Seminar Summary:

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. (see full course description)

 

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Training Course Syllabus:


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

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

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

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

Seminar Summary:

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. (see full course description)

print this agenda print agenda for the Understanding the FDA's Regulation of HCT/Ps and Successful Product Development Strategies training seminar

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