News in paediatric pharmacovigilance

Pharmacovigilance

News in paediatric pharmacovigilance

The guideline discusses the use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children; give information about how to adapt regulatory requirements to the pediatric population in the European Union; and discusses more specific topics as off-label use, medication errors, risk management plans and periodic safety update reports. 

 
The guideline applies to approved drugs with a pediatric indication or ongoing pediatric development, and to approved drugs with adults indication that are used to treat children.

 

EMA public consultation
Asphalion is part of one of the new working groups of AEFI

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