3D Tissue Models
Comparability at all Stages of Development
Hilton San Diego Resort

San Diego, California


   Biologics are constantly subject to change implementation, which
   necessitates physicochemical and biological comparability studies. The
   industry needs to ensure safety and efficacy, as well as regulatory
   approval, but does not wish to be over zealous. Comparability at all
   Stages of Development will present technological advances and provide
   industry case studies of physicochemical analyses, bioassays and
   pre-clinical and clinical studies for comparability after various
   types of change implementation. It will provide advice on developing a
   well thought-out risk assessment strategy offering huge financial
   advantage to the investigator, together with presentations from the
   European and US regulatory authorities and industry experts
   experienced in regulatory interaction.

Schedule of Presentations:

Wednesday, April 14, 2010
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