Investigators have to comply with GCP guidance and regulation while integrating clinical trial activities into their routine care environment. This is an increasing challenge, and inspectors often see only the compliance aspects of this integration. The interpretation and application of guidance and regulation are not always clear to investigators...

This conference is a yearly event organised by the EFGCP Children Medicines Working Party in collaboration with DIA and Regulators to take stock of the progress achieved in the paediatric field after 10 years of Paediatric Regulation and, to move the discussion forward. It provides a unique multi-stakeholder platform to share and discuss important...