Course - Los Angeles, CA, United States
To better understand what the developing FDA biosimilar pathway might look like, this course will closely examine 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.
Biosimilars – Understanding the Regulatory Challenges
Thu, Jun 13, 2013 - Fri, Jun 14, 2013
The Hilton Los Angeles Airport (LAX)
5711 West Century Blvd., Los Angeles, CA 90045, United States
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