FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering Training
22-23 Oct 2020
Online Event
Description
Topics
FDA regulatory approvals for the use of stem cells in medicine
FDA guidance documents for stem cell technologies
Currently approved use of stem cells in medicine
Global approval of stem cell technologies
Fundamentals of stem cells
What is all the excitement about
Definitions
Sources of stem cells
How to control stem cell differentiation
Avoiding immune system clearance of stem cells
Incorporating stem cells into biomaterials
Research examples post-clinical approval
Research examples pre-clinical approval
Future thoughts on approaches for regulatory approval of stem cell technologies
Outlook for new technologies
Remaining hurdles
Strategies for commercializing stem cell technologies
FDA regulatory approvals for the use of stem cells in medicine (continued)
The use of human cells, tissues, and cellular and tissue-based product criteria and "Minimal Manipulation Standard"
How the FDA regulates regenerative treatments and therapies
Regenerative products as medical devices
The drug and biological approval process
Applicable good manufacturing and good laboratory practices
How to design appropriate clinical trials
FDA and other federal agency enforcement action
Product labeling, marketing and advertising
Who should Attend
Quality professionals
Senior quality managers
Compliance professionals
Regulatory professionals
Manufacturing engineers
Production supervisors
Design engineers
Production engineers
Contract manufacturers
Labelers and private labelers
U.S. agents of foreign corporations
Importers and custom agents
Quality engineers
Process owners
Document control specialists
Quality auditors
Medical affairs
Record retention specialists
Financial advisors and institutional investors
Legal professionals
Graduate students
Patent lawyers
Clinicians
Academic faculty and professors
Entrepreneurs
Past Events
FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering Training - 22-23 Oct 2020, Online Event (85154)
Important
Please, check "FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering Training" official website for possible changes, before making any traveling arrangements
Event Categories
Business: Quality assurance
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Medical laboratories, Medical technology, Pharma
