Gulf Cooperation Council (GCC) Biosimilar Medicinal Products Workshop
Date:
19/04/2011 to 20/04/2011
Location:
Riyadh, Saudi Arabia
This training workshop is being organised as part of the European Medicines Agency's contribution to international co-operation and harmonisation of medicine approval standards, under the auspices of International Conference of Harmonisation (ICH) Global Co-operation Group (GCG). Over 60 participants are attending this workshop which is open to all Middle Eastern economy stakeholders and interested parties.
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Agenda - GCC Biosimilar Medicinal Products Workshop (PDF/165.18 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - ICH and EU regulatory framework and the role of the European Medicines Agency (EMA), Falk Ehmann, EMA (PDF/778.82 KB)
First published: 23/06/2011
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Presentation - EU Biosimilar Regulatory Framework II, Falk Ehmann, EMA (PDF/692.65 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - EU Biosimilar regulatory framework – Non-Clinical and Clinical Aspects III, Falk Ehmann, EMA (PDF/502.28 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - Quality of biologicals, Kowid Ho, Afssaps (PDF/1.05 MB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - Manufacturing process of biologics, Kowid Ho, Afssaps (PDF/397.01 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - Control of biologics, Kowid Ho, Afssaps (PDF/456.45 KB)
First published: 23/06/2011
Last updated: 23/06/2011 -
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Presentation - Comparability, Kowid Ho, Afssaps (PDF/183.88 KB)
First published: 23/06/2011
Last updated: 23/06/2011