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Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, Biosimilars, Post-Approval Supplements)

 
  March 31, 2016  
     
 
Center for Professional Innovation & Education, Inc., Berlin, Germany
September 5 & 6, 2016


This course will give participants the necessary overview of the US Food and Drug Administration's (FDA) current responsibilities, procedures, guidances and regulatory pathways that affect the review and approval of chemical drugs, biologicals, biopharmaceuticals, biosimilars and chemical generics. Using the ICH Common Technical Document (CTD) module format outline, significant Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be analyzed and discussed, as a basis for strategic planning for both submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements, as well as for holding key meetings with the FDA.

Similarities and differences between clinical INDs and market approval dossiers, and between the various market approval dossiers (NDAs, BLAs, and ANDAs) will be discussed. Other topics to be discussed include Fast Track pathway, comparison of chemical generics with biosimilars, FDA's commitments under the User Fee Acts (PDUFA, BsUFA, GDUFA) and FDA's evaluation of industry's performance in meeting its requirements and expectations for review of drug products.

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers:

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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