Gulf Cooperation Council (GCC) Biosimilar Medicinal Products Workshop

• Date:
  Tuesday, 19 April 2011, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Agenda - GCC Biosimilar Medicinal Products Workshop

Presentation - ICH and EU regulatory framework and the role of the European Medicines Agency (EMA), Falk Ehmann, EMA

Presentation - EU Biosimilar Regulatory Framework II, Falk Ehmann, EMA

Presentation - EU Biosimilar regulatory framework – Non-Clinical and Clinical Aspects III, Falk Ehmann, EMA

Presentation - Quality of biologicals, Kowid Ho, Afssaps

Presentation - Manufacturing process of biologics, Kowid Ho, Afssaps

Presentation - Control of biologics, Kowid Ho, Afssaps

Presentation - Comparability, Kowid Ho, Afssaps