EMEA workshop on Monoclonal Antibodies
Date:
02/07/2009
Location:
London
The EMEA workshop on biosimilar monoclonal antibodies (mAbs) was intended to discuss the feasibility of the scientific development and authorisation of monoclonal antibodies via the European biosimilar regulatory pathways. 159 people including health care professionals, academics, representatives from regulatory agencies in the European Union (EU), United States (US) and Canada, and 40 biopharmaceutical companies located worldwide attended the workshop. Participation was by invitation only.
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Agenda - EMEA workshop on biosimilar monoclonal antibodies - Programme (PDF/65.12 KB)
First published: 01/07/2009
Last updated: 01/07/2009
EMEA/CHMP/BMWP/494490/2008 -
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EMEA Workshop on the feasibility of Biosimilar monoclonal Antibodies - Welcome - Xavier Luria (PDF/54.68 KB)
First published: 02/07/2009
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Towards biosimilar monoclonal antibodies - Pros and cons - Christian K Schneider (PDF/2.14 MB)
First published: 02/07/2009
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Session 1 - CMC - Innovator Industry Presentation - Prof. Georg-B. Kresse (PDF/1.04 MB)
First published: 02/07/2009
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EGA-EBG's quality perspective on Biosimilar mAbs - Martin Schiestl (PDF/169.49 KB)
First published: 02/07/2009
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Session 1 - CMC - Kowid Ho (PDF/344.52 KB)
First published: 02/07/2009
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Session 2 - Non-Clinical Issues - Innovator Industry Presentation - Danuta Herzyk (PDF/152.47 KB)
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EGA-EBG's Non-Clinical perspective on Biosimilar mAbs - Alexander Berghout (PDF/162.97 KB)
First published: 02/07/2009
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Regulator, Thinking - Non-clinical session - B. Silva Lima (PDF/15.1 KB)
First published: 02/07/2009
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Session 3 - Clinical Issues - Innovator Industry Presentation - Jay P. Siegel (PDF/303.6 KB)
First published: 02/07/2009
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Biosimilar mAbs - Clinical issues - Regulatory perspective - Christian K Schneider (PDF/1.7 MB)
First published: 02/07/2009
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Biosimilar mAbs - Outlook - Christian K Schneider (PDF/973.71 KB)
First published: 02/07/2009
Last updated: 02/07/2009