The EUCROF Paediatric Working Group and the Bambino Gesù Paediatric Hospital organise the paediatric training event entitled: “Essentials of Paediatric Clinical Research” which will be held in Rome at the Bambino Gesù Paediatric Hospital on Tuesday 12 September 2023 from 8.30 a.m. to 4.30 p.m.

TRAINING OBJECTIVE

Give an overview of the regulatory landscape for paediatric research, review specifics and most important challenges with corresponding solutions in paediatric drug development and review specifics and most important challenges with corresponding solutions in paediatric drug development.

Following the training, the participants will be familiar with the ethical and regulatory issues, specific protocol considerations and age groups, Informed Consent and Assent processes, drug formulations, safety specificities, recruitment, enrollment, and clinical monitoring specificities, as well as site interactions, relationships with paediatric research networks and infrastructures. Participants will be prepared to plan and execute paediatric clinical trials in any of the age groups which will result in obtaining higher quality data.