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New GVP Product- or Population-Specific Considerations IV published by EMA

EMA

EMA published the new good pharmacovigilance practice (GVP) Product- or Population-Specific Considerations IV containing specific considerations about pharmacovigilance for the pediatric population. It explains the importance of pediatric pharmacovigilance, the difference with regular pharmacovigilance and provides guidance on how to best use the current tools and processes to obtain an adapted safety monitoring system in children. In addition, it clarifies the roles and competences of the committees concerned and advises on regulatory requirements for the pediatric population in the European Union.

 

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