Advanced Therapy Medicinal Products - from Clinic to Market (cell therapy, gene therapy and tissue e (Advanced Therapy Med)
Venue: Green V Sustainable Center
Location: South San Francisco, California, United States
Event Date/Time: Sep 14, 2009 | End Date/Time: Sep 14, 2009 |
Registration Date: Sep 10, 2009 | |
Early Registration Date: Aug 12, 2009 |
Description
Topics covered in this seminar include:
• The EU regulatory framework for Advanced Therapy Medicinal Products (gene, cell therapy and tissue engineered products)
• Opportunities in the EU regulatory landscape, especially for treatment of rare diseases: How can they benefit your Company?
• Current and future regulatory guidelines: Latest develop¬ments and implications for your company and product portfolio
• What are the EU CMC/quality issues/requirements at various stages of development?
• Preclinical program: EU regulatory expectations - rational approach
• Clinical trials with Advanced Therapy Medicinal Products in the EU
This is an exciting half-day workshop for regulatory professionals, project managers, product development team members in the biopharmaceutical industry to gain insight into the regulation of advanced medicinal products from clinic to market.