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

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

Online Registration is now CLOSED. Onsite registration will be available. 


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




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