null Joint EDQM-EMA Event on Biosimilars

European Pharmacopoeia 08/02/2017 On-demand video

The programme was designed jointly with the EMA to enable participants to expand their knowledge and familiarise themselves with the current regulatory framework in the field of biosimilar products.

This programme consists of:

  • an overview of the European Union regulatory framework and the role of the EMA within this framework,
  • an outline of how the Ph. Eur. is placed in the above framework. The main purpose  being to clarify the role of monographs and how they should be applied,
  • a presentation on quality assessment of biosimilars, given by an EU regulator with practical experience in this area.

The session finishes with a 90-minute panel discussion with the speakers.

Target audience 

This workshop is of interest to national regulatory bodies and professionals working in pharmaceutical companies in quality control, development, manufacturing, and regulatory affairs in the field of biological products.

Duration: 4 hours.

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