Joint EMA / European Directorate for the Quality of Medicines and Healthcare (EDQM) event on biosimilars

• Date:
  Wednesday, 8 February 2017, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines and Healthcare (EDQM) designed this programme to enable participants to expand their knowledge and familiarise themselves with the current regulatory framework in the field of biosimilar products. A European Union (EU) regulator with practical experience in this area will present an overview of the EU regulatory framework and EMA's role within this framework, an outline of where European Pharmacopoeia (Ph. Eur.) fits in the framework and the role of Ph. Eur. monographs and how to apply them and perspectives on quality assessment of biosimilars.