Institutional review board - Ethic Committee Expert Bologna, Metropolitan City of Bologna, Italy
Since February 2012
I manage the scientific secretariat according to Ministerial Decree 8 February 2013 and previous, in the schedule of the EC meeting and, as responsible of the OsSC for the Ethic Committee and for the Ausl di Bologna, I deal with the communications to AIFA.
I meet Sponsor and/or CRO before the starts and when the trials are in progress with the Principal Investigator and his team during the pre-visit study and during the possible audit. I have an important regulatory background that came in handy in every occasion. I deal with all research phases including compassionate use, medical devices research and not least the observational studies. I have acquired skills in the methodology of the research as a member of SU.ME.RI, a group of people with different skills which support PI to submit protocols methodologically correct.
Insights about the EC-BI and the management of the drug at the following link: http://www.ausl.bologna.it/professionisti/ce
For some years now I have the good fortune to work with the Foundation GIMBE. With the President, Nino Cartabellotta, we translate documents into Italian, we write articles, I'm teacher for one course about clinical trials, and from this year I began a close collaborazone on a project that involves also the AIFA.
AdaptabilityAnalytical thinkingInnovative thinkingInterest in knowledgeProblem solving
Clinical monitoringClinical researchClinical pharmacologyClinical trial audits and inspectionsClinical trials
Skills and Expertise
Interact with physicians Interact with nurses Monitor a clinical studyPre-study procedures Coordinate ethics committeeEthics committee applicationEthics committee submissionsInteract with ethics committeeCoordinate with the ethics commiteeAssess business and scientific ethics
Bachelor in Pharmacy from Alma Mater Bologna in 2011