clinical trials – GAPP https://www.pediatricpain.eu GAbapentin in Paediatric Pain Wed, 29 Jun 2016 05:40:26 +0000 en-GB hourly 1 Site Initiation Visits https://www.pediatricpain.eu/site-initiation-visits/ https://www.pediatricpain.eu/site-initiation-visits/#respond Mon, 06 Jun 2016 17:29:06 +0000 https://www.pediatricpain.eu/?p=2012 The patients recruitment is close to start in France and in the Netherlands, where the 6 clinical sites (Hopital Robert Debré in Paris, Hopital Necker […]

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The patients recruitment is close to start in France and in the Netherlands, where the 6 clinical sites (Hopital Robert Debré in Paris, Hopital Necker in Paris, Hopital La Timone in Marseille, Hopital Roger Salengro in Lille, Erasmus Universitair Medisch Centrum Rotterdam-Sophia Kinderziekenhuis in Rotterdam and University Medical Center Utrecht, Wilhelmina Kinderziekenhuis in Utrecht) will receive the SIV (Site Initiation Visit)  in September 2016. The other 6 participating sites in Albania (Qendra Spitalore Universitare Nene Tereza), in Germany (Universitaetsklinikum Erlangen), in Greece (Geniko Nosokomeido Paidon I Agia Sofia) and in Italy (Azienda Ospedaliero – Universitaria Consorziale Policlinico di Bari, Azienda Ospedaliera di Padova and Istituto Giannina Gasliniwill receive the SIV in October 2016.

The site initiation visit (SIV) will be attended by the site principle investigator and his/her team of co-investigators and study nurses. During the SIV, the study staff will be trained in study conduct in accordance with Good Clinical Practice (GCP). With the release of the Investigational Medicinal Product (IMP), expected in August 2016, all the sites will be able to start recruitment of first eligible patients.

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GAPP at the Open Meeting in Tirana https://www.pediatricpain.eu/pediatric-clinical-trials https://www.pediatricpain.eu/pediatric-clinical-trials#respond Tue, 25 Aug 2015 14:56:23 +0000 https://www.pediatricpain.eu/?p=1625 On May 18th, 2015, the GAPP Project was presented at the DEEP Open Meeting “Networking and Innovation for local development”, organised by Consorzio per Valutazioni Biologiche […]

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On May 18th, 2015, the GAPP Project was presented at the DEEP Open Meeting “Networking and Innovation for local development”, organised by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) in collaboration with the University Hospital Center “Mother Teresa” (UHCT) in Tirana (Albania).

The meeting was promoted in the framework of the EU-funded project DEEP (DEferiprone Evaluation in Paediatrics) and aimed to foster clinical research in Albania and raise attention on the importance of European Networks for the creation of synergies to spread excellence and attract European funding.

Structured into 2 thematic sessions (Clinical Research in Albania and Networks and Projects in a Global Context), the meeting provided the opportunity to discuss many topics related to the conduct of pediatric clinical trials, such as the barriers that researchers encounter to the timely development of safe and efficacious medicines especially for children; the related need to set up infrastructures for each study in each site; the role of collaborative efforts in medicine and research. In particular, participants stressed the importance of the international cooperation in the activities performed in clinical research as a way to promote interdisciplinary participation through high-impact, mission-driven collaborations with leading health providers, governments and educational institutions.

On this occasion, the GAPP Project was presented by Alketa Hoxha (University Hospital Center “Mother Teresa, Faculty of Technical Medical Sciences, University of Medicine Tirana, Albania), in the “Networks and projects in a global context” session with a presentation entitled “Participating in an international research network: the experience of Mother Teresa University Hospital in the GAPP Project”.

Here you can download the GAPP presentation.

For further information on the scientific events, please download the brochure of the event and the abstracts. Here you can download all the presentations of the Open Meeting.

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