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Midwest Regional Forum March 2018
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Thank you to all who participated and helped make this program a success!

We look forward to seeing you again on October 23, 2018 for the Fall Midwest Regional Forum on Accelerated CMC Development at Loews Chicago O'Hare Hotel. More information coming soon! 

 

Thursday, March 15, 2018 - 9:00 AM - 3:30 PM

Hyatt Regency St. Louis at the Arch
315 Chestnut Street
St. Louis, MO 63102

 





Clinical Relevance for Setting Specifications


 

The CASSS Midwest Regional Forum is committed to bringing job-relevant education to the local biopharmaceutical and biotechnology community. These programs are dedicated to facilitating the sharing of information and best practices in order to advance scientific knowledge across industry, academia, and regulatory agencies. This full day program will feature presentations on clinical relevance for setting specifications, an interactive panel discussion, roundtable discussions, peer-to-peer learning, and networking opportunities.

 

 Learning Objectives:
1. Discuss current regulatory perspectives on clinically relevant specifications for BLA submissions.
2. Evaluate industry best practices for specification setting, including:
    a. Statistical evaluations
    b. Introducing variability
    c. Control strategy based on CQA analysis

 

 

 

 Want more information? Check out the "More in this Section" dropdown box at the top of the page!

Or contact CASSS at 510-428-0740 or alingel@casss.org

 


  

 

 

 
 
 
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