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CASSS Bay Area Discussion Group June 2016
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Thursday, June 9, 2016, 9:00AM - 3:30PM 

South San Francisco Conference Center, South San Francisco, CA
 


 



Building a "Quality" Dossier from Phase 1 and Beyond


  

Thank you to all who participated in the CASSS Bay Area Discussion Group! 
Mark your calendars for our next event, "Successful Strategies for Tech Transfers" on Thursday, October 13, 2016.

Development of a “Quality” Dossier containing the appropriate level of Chemistry, Manufacturing and Control information is an integral element of global regulatory submissions to support clinical development programs. First and foremost, regulations and guidance must be considered as the dossier is being prepared. Additionally, the phase of development, molecule complexity, and available molecule knowledge are key elements to consider when developing the dossier content. This meeting will provide an interactive forum for individuals from academia, industry and the FDA to come together to discuss the challenges and best practices for preparing a phase appropriate “Quality” Dossier. Key discussion topics will include, establishing specifications, analytical method development, structural characterization, stability approaches, and leveraging platform information when preparing dossiers to support global clinical programs. The meeting format is designed to provide attendees the opportunity to hear current perspectives from the FDA and Industry and to network through participation in facilitated small group discussions.              

 

About the Discussion Groups:
CASSS began as a local, non-profit chromatography discussion group in the San Francisco Bay Area. Although the society's offerings have now grown to include multiple North American and international scientific symposia and its members span the globe, CASSS still provides local educational and networking opportunities for scientists in Northern California, greater Washington DC, and Midwest areas. The CASSS Discussion Groups are your opportunity to meet others who understand what you do, in an informal setting, and exchange new ideas.







 

 

 

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