San Francisco, California
London, United Kingdom
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.
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
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
Note: Use coupon code NB5SQH8N and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.