EMA Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: pediatric population

New Guideline open for comments until 13th October 2017

Adverse reactions in the pediatric population need a specific evaluation, as they may substantially differ - in terms of frequency, nature, severity and presentation - from those occurring in the adult population. The importance of performing specific research in pharmacovigilance targeting the pediatric population has been recognized and established, and modalities of data collection should take into account that medicines in the pediatric population have a different utilization pattern and often are used off-label.

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