Speakers

Dr Niklas Ekman has a background in molecular cell and cancer biology. He joined the Finnish Medicines Agency in late 2006 and spent the next 11 years assessing the quality/CMC of biological medicinal products, with a focus on biosimilars. His responsibilities included assessing European Medicines Agency (EMA) centralized marketing authorization applications, national clinical trial applications, and providing scientific advice. Dr Ekman currently heads the CMC/biological section at the Finnish Medicines Agency. At EMA, he is a member of the Biologics Working Party (BWP) and the vice-chair of the Biosimilar Medicinal Products Working Party (BMWP). Internationally, he is a member of the ICH M18 working group and a temporary advisor to WHO