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REGISTRATION NOW OPEN!
8th Annual Somatic Cell Therapy Symposium
September 22-24 2008
Bethesda, Maryland
PROGRAM OBJECTIVES
The Somatic Cell Therapy Symposium is a forum designed to engage FDA, academia, and industry in an open dialogue on regulatory issues for:
a) Translation of basic laboratory research findings into therapeutic products suitable for evaluation in clinical trials,
b) Product manufacturing in the context of early and late phase clinical trials, and
c) Preparation and maintenance of IND and biologics license applications for cellular therapy products.
2008 Meeting Objectives:
To describe development of novel cellular therapies such as:
· Products manufactured using human embryonic stem cells
· The non-homologous use of cord blood products
· ‘Enabling’ technologies for cellular therapeutics
To describe the considerations for a risk-based approach to:
· Ancillary reagent and starting cell qualifications
· Product development
· Manufacturing modifications
To discuss:
· Microbial testing of cellular therapeutics
· Manufacturing changes: operational impacts and reporting to the FDA.
· Vendor recalls
Click here to see Program
REGISTRATION
Meeting Co-Chairs:
Janice Davis-Sproul, MAS, MT(ASCP)SBB
Johns Hopkins Medical Institutions
Baltimore, MD
Dr. Elizabeth J. Read, MD
Blood Systems Research Institute
San Francisco, CA
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