Our experienced teams are poised to provide practical advice on the management and reporting of adverse reactions occurring in the pediatric population.
The importance of performing tailored pharmacovigilance research in the pediatric population has been established and entrenched in GVP. Collection of PV data should take into account that in the pediatric population, medicines have different utilization patterns and are often used off-label.
Our PV experts can:
- Assist you to evaluate the methods used to minimize risk of adverse reactions in the adult population and adapt them to pediatric patients, taking into account all the aspects specific to them e.g., differing susceptibility to ARs to that observed in adults due to growth and maturation, limited numbers of subjects in pediatric clinical trials or medication errors
- Offer practical advice on the management and reporting of adverse reactions occurring in the pediatric population, such as: prerequisites of pediatric ICSRs, the usefulness of PASS on pediatrics and on signal management activities and the expected differences when compared to adults, due to the different utilization, prescription, adverse reaction susceptibility and clinical presentation.