Print Page   |   Contact Us   |   Sign In   |   Register
Community Search
Midwest Regional Forum March 2018
Share |
 

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

 

 

 

 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

 


  

 

 

 
 
 
more Calendar

5/14/2018 » 5/16/2018
CMC Strategy Forum Europe 2018

Featured Members
John E. Schiel, NISTVisit the CASSS News page to get to know John Schiel!

Membership Software Powered by YourMembership  ::  Legal