On June 30 and July 1, 2016, the 4th General Assembly meeting took place in Rotterdam, the Netherlands, with the participation of the whole GAPP Consortium.
The meeting provided an update on the achievements and difficulties encountered toward the implementations of specific project tasks, the reasons for some delays and the mitigation strategies set into place in order to overcome such obstacles.
The meeting opened with an overview of the pharmaceutical company, Dompè, on the new liquid formulation specifications of Gabapentin as well as with a timeline for the drug production, setting the 3rd week of July as starting point, followed by packaging and final release from Quality Assurance.
Moreover, an update of the clinical studies has been provided, with a particular focus on:
This meeting gave also the chance to discuss the main changes occurred in relation to the project plan and activities’ responsibilities.
The second meeting day provided an update on the GABA-1 Study management procedures, also including a full account about the informative consent set up for the study trials.
After presenting the web-based ICH-Good Clinical Practice Training Course, the organization of the trial infrastructure, that PHARM set in place for the management of GABA-1 and GABA-2, has been described. The meeting ended with the presentation of the e-CRF, created according to the study protocol in order to enable data to be systematically reviewed and analyzed, and a practical simulation on how data can be inserted in the e-CRF.
The meeting represented an excellent opportunity to foster fruitful scientific debates and to exchange information. Advancement in the work packages and partner involvements where discussed in order to build a perfect working basis for the forthcoming activities.