A draft framework about paediatric clinical trial preparedness has been published by Enpr-EMA and is open for public consultation

A draft framework about paediatric clinical trial preparedness has been published by Enpr-EMA and is open for public consultation

The recommendations by the Enpr-EMA working group on trial preparedness have now been published and are available at this link.

Stakeholders are invited to submit comments to enpremasurveys@ema.europa.eu by 15 November 2019.

The document has been linked and highlighted on the EMA’s stakeholder landing pages, and disseminated to relevant EMA contacts. You are encouraged to distribute it further.

The aim of this consultation is to identify potential gaps and present a more comprehensive view of the topic. Enpr-EMA will publish an updated version of the framework after the consultation phase.

TEDDY has provided its contribution participating in Action point 1 (Review the current regulatory guidance and academic publications in relation to the conduct of trials in the paediatric population to identify discussion on preparedness) and Action point 4 (Development of a prompt guide/questionnaire to be used in interviews and brainstorming sessions on trial preparedness with stakeholder groups).

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