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:

• the description of the finalized GABA-1 protocol design, inclusion-exclusion criteria, study schedule, patient enrolment and eligibility criteria, study drug titration, optimization and end of study tapering;
• the description of the GABA-2 protocol highlighting the specificities of GABA-2 and the potential difficulties due to morphine handling and administration;
• the progression state of every Work Package (WP) and deliverables and a general update of GABA-3 study.

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.

The post GAPP General Assembly meeting in Rotterdam 2016 appeared first on GAPP.

The meeting will be focused on a general update of the project activities, the progresses and achievements and the planning of future steps. In particular, the GABA-1 e GABA-2 protocol procedures will be presented in order to prepare the ground for the starting of the recruitment phase. In the same context of the GA meeting, the web-based ICH-Good Clinical Practice Training Course will be officially presented.

Here you can download the meeting agenda.

More details on the event are available on the GAPP website in the “News & Events” session.

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