Workshop on the 'Guideline on pharmaceutical development of medicines for paediatric use'
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Datum
- måndag, 1 december 2014, Hela dagen
Plats
- European Medicines Agency, Amsterdam, the Netherlands
The Quality Working Party is organising a workshop on the 'Guideline on pharmaceutical development of medicines for paediatric use'. The guideline has been in force as of February 2014 and is intended to provide additional guidance to pharmaceutical developers on quality aspects related to medicinal products for children between birth and 18 years of age. As more experience becomes available, further work is required to complement the guideline with additional recommendations on pharmaceutical development of paediatric medicines. The general scope of this workshop is to share the experience gained so far with the use of the guideline among stakeholders (regulators, healthcare professionals, academia and industry) and identify gaps in current knowledge. This workshop should be considered as a starting point for discussions.