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Biosimilars - Understanding the Regulatory Challenges

 
  July 10, 2015  
     
 
Center for Professional Innovation & Education, Inc., Los Angeles, CA
October 1 & 2, 2015


In the United States, much excitement has been generated since the passage of the Biologics Price Competition and Innovation Act (BPCI) of 2009. This law establishes an abbreviated market approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ with, a FDA-licensed marketed biologic. However, much confusion has arisen over exactly what this new abbreviated regulatory pathway actually means, and what it will look like when fully implemented by the FDA.

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:

John Geigert, Ph.D.

Specialties: Regulatory, Biotechnology, Management

John Geigert, Ph.D., RAC, is President of BioPharmaceutical Quality Solutions, which for the last 12 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry.

Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development for Cetus Corporation in Emeryville, CA. At these companies, he led the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products (4 recombinant proteins and 2 monoclonal antibodies) now commercially available in the U.S. and Europe.

He has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board, and served as an expert member of the USP Biotechnology Committee.

He obtained his B.S. in Chemistry from Washington State University, and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.

 
Deadline for Abstracts: n/a
 
Registration: CLICK HERE TO REGISTER
E-mail: info@cfpie.com
 
   
 
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