Enpr-EMA Werkgroep publiek-private samenwerking: aanbeveling netwerkconsultatie
You may have experienced in the past that developing drugs in children in quite a challenge: Pediatric indications differ from adult indications, incidences are much lower and sites are often less experienced and some are lacking a good infrastructure.
Several EnprEMA Working Groups have been established in the past to support clinical research in pediatrics. As one of these working groups, we are focusing on the communication between industry and networks, with the aim to get clinical research networks involved already at an early stage in the product development process, including PIP preparation and trial conduct. We hope that an early communication between industry and networks would result in more feasible PIPs and clinical trials with more realistic timelines and decrease the need for PIP modifications and deferrals.
We are now in the process of identifying sponsors who would like to participate in a pilot project to test proof our communication model. You can find the latter under
If you are planning to write a PIP in the next few upcoming months and you are interested to work closely with pediatric clinical research networks throughout Europe, we’d highly appreciate to enroll your PIP in our pilot project.
In case you are interested in the project, please let Dr Martine Dehlinger-Kremer know by latest 27 February 2019.
Dr. Martine Dehlinger-Kremer