Workpackage 10

Workpackage lead

Academic Lead: Dr. Vincent Grek (O4CP)

Workpackage objectives

O4CP will act as the co-sponsor of the study. As co-sponsor, O4CP will ensure that the the pharmaceutical development is performed according to the Good Clinical Practice.
Good Clinical Practice is an international ethical and scientific standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides the assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

Workpackage description

As industrial co-sponsor of the Program, O4CP will analyze, evaluate the risk/benefit, review and exploit all the data generated (quality, non clinical and clinical) during the project in order to obtain the Paediatric Use Marketed Authorization (PUMA) and to comply with all regulatory requirements, in particular safety issues.