Research and Markets - Understanding the FDA's Regulation of HCT/Ps and Successful Product Development Strategies: Two Day Seminar - Irvine, CA, United States - July 13-14, 2017
DUBLIN, April 05, 2017 /PRNewswire/ --
Research and Markets has announced the addition of the "Understanding the FDA's Regulation of HCT/Ps and Successful Product Development Strategies" conference to their offering.
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:
- 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
Agenda:
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
For more information about this conference visit http://www.researchandmarkets.com/research/s6js9c/understanding_the
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