Regulatory Affairs for Biologics

Venue: Drug Information Association, Inc.

Location: Horsham, Pennsylvania, United States

Event Date/Time: Mar 11, 2010 End Date/Time: Mar 12, 2010
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Discuss proven strategies to achieve regulatory compliance for the development of biologics.

What you will learn
• Difference between traditional biologics and biotechnology products
• Regulatory needs and requirements for biologics
• Unique aspects in the development of specific biologics such as vaccines and gene therapy
• Differences in how CBER views product development compared to CDER