CMC Strategy Forum Europe 2010

CMC Strategy Forum Europe 2010 Challenges Facing Biopharmaceutical Development in the Next Decade

 

 

 

 

ON-LINE REGISTRATION IS NOW CLOSED.  REGISTRATIONS WILL ONLY BE TAKEN ON-SITE.

Forum Co-Chairs:
Ilona Reischl, AGES PharmMed, Austria
Karin Sewerin, BioPharmaLinx AB, Sweden

The fourth annual CMC Strategy Forum Europe, organized by CASSS, An International Separation Science Society, offers a unique blend of topics that characterize the challenges facing the biotechnology industry in the next decade. A series of plenary sessions and workshops will enable attendees to participate in discussions that will help shape future directions in biopharmaceutical development. Topical plenary presentations and interactive workshops involving experts from global regulatory agencies, academia, and industry will include:

• Immunogenicity assessment of monoclonal antibodies for in vivo clinical use
• Managing biopharmaceutical drug product formulation changes
• Quality documentation for biologic IMPs in clinical trials
• Assessing comparability after changes to primary packaging and devices for biopharmaceutical products
• CMC challenges facing vaccine development
• Evolving approaches to Quality by Design

Professionals from the following functional areas are encouraged to actively engage in these important discussions:

• Process/Product Development
• Quality Assurance/Quality Control
• Regulatory Affairs
• Immunology
• Molecular and Cell Biology
• Analytical Development
• Manufacturing Sciences
• Clinical Pharmacology