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.
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.
Download the presentations
- Biosimilars - the regulatory framework by Peter Richardson, EMA
- Quality assessment of biosimilars by Niklas Ekman, BMWP member/FIMEA
- Ph. Eur. monographs and biosimilars by Emmanuelle Charton, EDQM, Council of Europe
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