Speakers -------- N/A 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.
|Wednesday, April 14, 2010|