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CMC Strategy Forum January 2018
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Method Qualification vs. Validation - What Does That Mean Now

 Forum Co-chairs:

               Nadine Ritter, Global Biotech Experts, LLC 
              
 CBER, FDA (TBD)
               CDER, FDA (TBD)
               Health Canada (TBD)

 Scientific Organizing Committee:

               Melody Gossage, Eli Lilly and Company, USA 
               
Mary Beth Pelletier, Biogen, USA
               
Jason Starkey, Pfizer, Inc., USA

 

 Prior Knowledge: Learning from our Successes and Failures to Improve Product Development and Manufacturing

 Forum Co-chairs:

               Julia Edwards, Allergan, USA
               
Joseph Kutza, MedImmune, A member of the AstraZeneca Group, USA
               
Heidi ZhangGenentech, a Member of the Roche Group, USA

Scientific Organizing Committee:

               Earl Dye, Genentech, a Member of the Roche Group, USA 
               
Robert Kuhn, Amgen Inc., USA
               
CBER, FDA (TBD)
               Joanna (Qing) Zhou, CDER, FDA
               
Health Canada (TBD)


 

 

  To visit the WCBP 2018 meeting homepage, click here

   
 

 

 



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