Participation in the Enpr-EMA pilot of the model for industry/network communication

Participation in the Enpr-EMA pilot of the model for industry/network communication

The Working Groups 3 (Establish collaboration between Enpr-EMA networks and industry) and 5 (Sharing good practices within Enpr-EMA and with industry) of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has launched an initiative to try to enhance communication between industry and networks. For this purpose, the experts participating to this working group have developed a model for communication between networks and industry sponsors and/or CROs in order to get clinical networks involved in the Paediatric Investigation Plan (PIP) process and facilitate early discussion with them. The hope would be that this communication would result in more feasible clinical trials/PIPs with more realistic timelines and decrease the need for PIP modifications and deferrals. A draft of the model has been distributed among some category 1 clinical research networks and sponsors. TEDDY Network has been invited to participate to this pilot in order to test the draft model. Since 2014, TEDDY Network has been member of Enpr-EMA and has provided its contribution in this paediatric Network offering its expertise and experience in conduct of paediatric clinical trials. This initiative will represent for TEDDY an ideal occasion to contribute in the promoting of good quality paediatric studies and facilitate the development of medicines in children.

June 4th, 2018|