Stefania Gamba

Background

About Stefania Gamba

II Level Master in, Pre-clinical and Clinical Development: technical-scientific, regulatory and ethical aspects. Degree in hospital pharmacy (specialization). Master Degree in CTF (Chemistry and Farmaceutical tecnology). Enabling the European database “Eudravigilance” AIFA-EMA. From 2013, 18 June current job collaboration contract holder in U.O.S.D. Epidemiologia, Biostatistica e Comitati, IRCCS Istituto Giannina Gaslini. From 2008, 1 May to 2013, 17 June Hospital Pharmacist in Hospital Pharmacy, IRCCS Istituto G. Gaslini, Genova. Main activities and responsibilities- Clinical trial (data management for the Ministerial Monitoring, management of the Investigational Medicinal Products, preparation of treatment of blinded studies, relationships with Clinical Monitor in clinical studies, participation in the Ethics Committees; management of eCRF for the aspects of the drug, evaluation of clinical trials, support to the principal investigators in the preparation of the documentations to be submitted to the ethics committee, management of Eudravigilance and OsSC (National Observatory of Clinical Trials on Medicinal Products)- Pharmacovigilance assistent- Member of ISS Project of drug's pediatric safety- Managing of internal hospital drug's distribution chain- Review prescriptions, speak with doctors and other medical staff for phoned in prescriptions- Inform patients about the medicines they are taking, any adverse side effects or harmful drug interaction- Toxicological drug counseling in pregnancy in collaboration with the Department of Genetics- Management of opioid drugs - Using data banks - Validation requirements and preparation of cytotoxic drugs - Using Programs “Prescribe” and “Cytosifo”, for the computerized prescription of anticancer drugs - Availability