Biosimilars – Understanding the Regulatory Challenges
Course - King of Prussia, PA, 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.
Organization: The Center for Professional Innovation & Education
(Courtesy of Molecule Model Biosimilars, via genengnews.com)
Biosimilars – Understanding the Regulatory Challenges
Mon, Nov 04, 2013 - Tue, Nov 05, 2013
Doubletree Hotel by Hilton, Philadelphia/Valley Forge
301 West Dekalb Pike, King of Prussia, PA 19406, United States
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