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Paediatric Clinical Trials: Need for Capacity Building

The EU Paediatric Regulation mandates that all new medicinal products are also evaluated in all paediatric age groups, unless an exemption (waiver) is obtained from the European Medicines Agency (EMA). This has led to an increased need to conduct clinical trials in children within and outside the European Union. Paolo Tomasi, Head of Paediatric Medicines, European Medicines Agency, explains why capacity building, and further changes in the perceptions and attitudes towards paediatric clinical trials among all stakeholders, is required.