Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation

Date: 20/03/2018
Location: European Medicines Agency, London, UK
This workshop, organised by the European Medicines Agency (EMA) and the European Commission, follows the publication of the Commission's ten-year report on implementation of the Paediatric Regulation and the state of paediatric medicines in the European Union. The aim is to discuss potential improvements of the implementation of the Regulation. It will explore opportunities regarding paediatric needs, timely completion of paediatric investigation plans (PIP), and processes and expectations for handling PIP applications. This workshop is a crucial step for the development of a concrete action plan to address challenges identified with medicine development for children in Europe. Invited stakeholders include patients, academia, healthcare professionals and industry. The deadline for expressions of interest is 14 February. EMA will select industry stakeholders via registered associations. The Agency will contact all selected participants on 1 March.

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