EDQM and EMA to clarify how Ph. Eur applies to biosimilars at event next week
The EDQM and EMA aim to clarify how European Pharmacopoeia (Ph. Eur) monographs apply to biosimilars at an event next week.
The event will be held at the European Directorate for the Quality of Medicines’ (EDQM) headquarters in Strasbourg, France on February 8.
Delegates – who can attend either in person or online – will be told how the Ph. Eur relates to European Union (EU) regulatory framework for biosimilars. The aim is to make clear the role of monographs and how they should be applied in the biosimilar assessment and approval process.
The event will also feature a presentation on biosimilar quality assessments Niklas Ekman, Senior Researcher (BMWP member), from the Finnish Medicines Agency in Helsinki.
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