The European CRO Federation – EUCROF organizes the workshop “Essentials of Paediatric Clinical Research” that will take place on 12 September 2023 at Bambino Gesù Paediatric Hospital, Sede San Paolo in Rome, Italy.
The event aims to give an overview of the regulatory landscape for paediatric research and review specific and most important challenges with corresponding solutions in paediatric drug development.
Following the training, 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, enrolment, 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.
Viviana Giannuzzi, senior researcher at Fondazione Gianni Benzi will participate in the event as speaker with a speech on the Informed Consent and Assent process per age group.
The workshop is intended for clinical research associates, central monitoring associates, study start up and regulatory affairs personnel, clinical trial managers, project managers, project directors, patient enrolment and retention specialists and any person involved in paediatric drug development.
A copy of the presentations will be provided. It can be downloaded following password receipt.
A training Certificate will be delivered as well.
More information and the full agenda here.