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European Medicines Agency Updates Guidelines on Pharmacovigilance for Pediatric Drugs

In mid-November, FDA announced that its sister organization, European Medicines Agency (EMA), has updated its guidelines of pharmacovigilance best practices for pediatric drugs. “This gives little patients a voice,” says Betsy Reid, COO of Paidion Research, a clinical research organization (CRO) focused exclusively on pediatrics and specializing in NICU and PICU populations (neonatal and pediatric intensive care).

The revised guidelines urge clinical trial sponsors to carefully monitor symptoms pediatric patients may not be able to talk about, because of their age. According to the EMA, symptoms including nausea and changes in mood may be under- or misreported in younger and developmentally-disabled children. The news bulletin advised sponsors to more fully and accurately report patient age in individual case safety reports (ICSRs), as well as age of onset of any drug reactions.

“We’ve long believed that because children respond to medical treatments differently than adults, pediatric clinical trials should be different from adult trials,” Reid commented. “This guidelines update by our European partners simply reinforces our philosophy: It’s just good science and optimal for safety and efficacy for trial design and execution to match the physiology and needs of the patient population, especially children. Our pediatric clinical pharmacology expertise combined with innovative pediatric regulatory strategies and trial methodologies allow us to provide best-in-class service to our drug development partners.”

To get the whole story, see the FDAnews Drug Daily Bulletin.

About Paidion
Paidion is a privately-held company located in the Research Triangle Park of North Carolina. Paidion provides clinical research coordination services that improve the health of children around the world by helping companies and organizations develop clinical trials for pediatric subjects. Paidion is dedicated to bringing safe and effective treatments to infants, children and adolescents.

Because children respond to medical treatments differently than adults, pediatric clinical trials should be different from adult trials. Paidion is committed to be the industry thought leader in establishing guidelines and best practices for the creation of treatment options for all children.

To learn how Paidion’s pharmacovigilance best practices assure pediatric patient safety and yield optimal research results, visit