GIQAR (Gruppo Italiano Quality Assurance nella Ricerca), established under the SSFA, has organized its XXIV National Congress at the Royal Continental Hotel of Naples (Italy) from May 27th to 29th, 2015. The event, entitled “ La Qualità e le GXP: l’asticella si sposta sempre più in alto” (Quality and GXP: the bar is moved higher and higher) wanted to emphasize the effort to allow compliance with new laws with respect to GXP and maintain a solid quality system. The most important legislative innovation in this context, is represented by the new European Regulation on Clinical Trials that will undoubtedly result in an adjustment of the quality systems to implement the innovations planned. In addition, the adaptation to new technologies in the GXP (e.g. Good Laboratory Practice), where studies on Gene Therapy should be carried out according to GLP, was highlighted.
About Good Clinical Practice, it was discussed the quality in observational studies and non-profit, issues related to the use of electronic CRF and monitoring “based on risk”. With regard to the pharmacovigilance, topics as PASS Studies, Conflict of interest between QPPV and QA, Privacy, interaction between PV and other business functions, and Weaknesses of GVP were treated.
The congress was composed by six sessions, plus a special section entirely dedicated to the presentation of Posters on the various topics covered during the GXP, QA and the other relevant sessions.
Within the poster session, Dr. Silvia Morgagni, CVBF Clinical Quality Assurance, presented a poster entitled “The challenges and the opportunity of conducting a pediatric clinical trial in Albania in compliance with European guidelines“, as a reference to the presentation titled “Studi clinici in pediatria: CI nei minori” (Clinical trials in pediatrics: IC in the minors) held by Dr. S. Ceccotti (Istituto di Ricerca Servier of Rome).
In her poster, Dr. Morgagni described the importance of the involvement of a non-European country like Albania in the DEEP-2 study, and focused the attention on the strengths and weaknesses of conducting a GCP clinical trial in Albania, which has not yet transposed the ICH-GCP within its legal framework. Indeed, specifically after the entry into force of the new Albanian law concerning clinical trials (which took place in July 2014) and forthcoming implementation decrees, it was generally recognised the necessity of conducting clinical trials in qualified hospital, getting the approval from the Ethics Committee and the authorisation of the Ministry of Health, seeking the informed consent, providing insurance coverage and finally the need of stopping/discontinuing the trial if required by the EC.
Dr. Morgagni concluded her intervention emphasising that, after the starting date of the clinical phase of the study in Tirana (on April 2015), two patients were already enrolled and up to 20 patients are expected to be enrolled in the study, thus underlying the exponential growth of this country in offering many expertise and improving its facilities and infrastructures.
Here you can download the DEEP poster.