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New guidance on informed consent for paediatric clinical trials published by EMA

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Published on: 25 January 2021

Published by LNB News

LNB News 25/01/2021

Document Information

Issue Date: 25 January 2021

Published Date: 25 January 2021

Jurisdiction(s): United Kingdom

Article summary

The European Medicines Agency (EMA) has published a new document on informed consent guidance for paediatric clinical trials with medicinal products. This initiative aims to create a tool containing the current ‘EU legal framework and ethical requirements’ to be used as guidance by stakeholders when conducting paediatric clinical trials. The document includes tables with questions to be addressed, elements to be considered, and relevant information to be provided for each age group. The guidance has been elaborated by the European network of paediatric research at the EMA.

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