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Biosimilars – Understanding the Regulatory Challenges

  May 01, 2013  
Center for Professional Innovation & Education, Inc., King of Prussia, PA
Nov. 4 & 5, 2013

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.
Organized by: Center for Professional Innovation & Education
Invited Speakers: Contact info@cfpie.com for a list of course instructors
Deadline for Abstracts: n/a
Registration: http://www.cfpie.com/showitem.aspx?productid=130&source=hummolgen
E-mail: info@cfpie.com
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