Center for Professional Innovation & Education (CfPIE), Los Angeles, CA
June 25 & 26, 2012
To better understand what the developing FDA biosimilar pathway might look like, this course will examine closely the existing regulatory guidelines from the European Medicine Agency (EMA) and the World Health Organization (WHO) and compare them to the draft FDA guidances. Insights and practical suggestions to help your company enter the biosimilar biological product market will be provided by examining what has worked, and what has not, for the existing market-approved EMA biosimilars and FDA follow-on-proteins.
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