The GAPP preliminary meeting opened its first session on July 13th, 2013, at DOMPÉ SpA in Milan, Italy, gathering 11 official partners of the project. Topics such as the elaboration of investigational and clinical/enrolment strategies, project feasibility and study population were discussed, highlighting the entire structure of the project.
As Prof. Adriana Ceci pointed out during the meeting, GAPP is a peculiar project, having to be compliant with two important reference documents: the Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and the rules and regulations of FP7 financed actions. She also underlined the requirement of completing a PIP (Paediatric Investigation Plan) for every new drug to be put on the market and the special Paediatric Use Marketing Authorisation (PUMA) which is GAPP’s final objective.
The meeting ended in the afternoon with a session on management and organizational issues, establishing timelines and clarifying responsibilities. The Managing Director of the Coordinator also underlined that the Project has been approved and hopefully the Grant Agreement with the European Commission will be subscribed soon. Starting date of the GAPP Project could be 01/07/2014, that is the first available date to ensure an optimum start of a hopeful, encouraging crusade against chronic pain.
