Event Detail

Regulatory Affairs for Biologics
March 11, 2010 - Horsham PA UNITED STATES

Drug Information Association, Inc

susan.mazak@diahome.org

Learn Regulatory Requirements for Biologics 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

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