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Konferenz
Immunogenicity for Biologics16.09.2008 - 17.09.2008
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Veranstaltungsort:
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Informa Life Sciences
29 Bressenden Place,
SW1E 5DR London
Großbritannien
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Themengebiete:
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Analytik; Bioanalytik; Biotechnologie, allgemein; Pharma; Recht, Gesetze/Verordnungen
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Veranstalter:
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Informa Life Sciences
PO Box 406
KT14 6WL Byfleet
Großbritannien
Tel.: +44 (0)20 7017 7481
Fax: +44 (0)20 7017 7823
http://www.informa-ls.com
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Beschreibung:
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Presenting ALL NEW data on design and validation of assays, pre-clinical and clinical developments, regulatory requirements, risk management and formulation.
Join us in Hamburg to hear presentations on how to successfully develop screening, confirmatory and neutralising assays. Our interactive panel sessions will ensure you gain the most from this 4 day event. Plus, don’t miss our 14 case studies; learn from those with hands-on, practical experience and take this back to your company.
Programme highlights for 2008:
• Genentech, Pfizer and The Health Protection Agency present detailed case studies on neutralising assays. This year the design and validation of assays have been split into two separate sessions so that you can gain an in-depth and thorough understanding of this challenging area. With a whole day dedicated to this hot topic you can ensure you come away with the tools to gain meaningful results.
• Join leading academic and industry experts, Professor Tudor Arvinte, University of Geneva, and Dr Robert Müller, F. Hoffmann-La Roche to assess the impact of different formulations on the immunogenicity of biological drugs.
• Incurred sample stability – with the FDA actively driving this forward how can industry respond effectively? Hear Abbott’s experience with Dr Stephanie Fischmann: Application of a homogeneous ECL bridging assay for the determination of Tox data for a mAb in Cynomolgus Serum with Incurred Sample Reanalysis (ISR).
• In April 2008, the EMEA guidelines on immunogenicity assessment of biotechnology-derived therapeutic proteins came into effect. Join the Paul-Ehrlich-Institute to assess the impact of these guidelines on your company.
• Risk management strategies – What studies should be done from a risk management perspective? How many patients should be committed to a study? Minimise the risk of immunogenicity for your drug product by learning from a detailed case study presented by Merck Serono.
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Weitere Informationen:
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http://www.informa-ls.com/immuno
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