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PedCRIN Webinar: Tools for the management of paediatric trials: handling biosamples and assessing causality of adverse events

12 March 2021

Our first webinar will be dedicated to the tools for managing paediatric trials. The speakers are  Viviana Giannuzzi from FGB (Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus) and Cristina Manfredi from CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche).

Brief summary

Managing paediatric clinical trials is a challenging endeavour due to the intrinsic characteristics of the paediatric population: the limited number of eligible patients, the differences in pharmacokinetics and pharmacodynamics between children and adults and also among children of different ages, the need for implementing ad hoc study procedures, the ethical considerations and the general perception that paediatric patients are vulnerable study subjects all unite to raise the complexity of clinical studies.

PedCRIN developed and/or adapted existing tools to be used for the setup and management of these studies. This webinar will present two different instruments:

  1. A checklist developed to help researchers, sponsors and other affiliated personnel  actors to verify that all key aspects required to properly manage samples and related data in the context of paediatric trials are taken into consideration.
  2. A visual algorithm based on the Naranjo scale and specifically adapted for the paediatric population to help researchers in their assessment of causality of adverse events occurring during a clinical study.

Date and Time

Wednesday, April 7th 2021 

1:00 PM CEST

Registration

Free registration on this link

Mini project website