Giulia Esposto Email & Phone Number

Knowledge of the Regulatory Guidelines. Assessment of country requirements and management of the drug regulatory activities (CTA, New registrations, renewals and variations) in Extra-EU countries (APAC area)

- Perform Regulatory, Start up process of clinical studies and Maintenance activities according to applicable regulations, SOPs and work instructions - Prepare site regulatory documents, reviewing for completeness and accuracy -Review, prepare and negotiate site contracts and budgets with sites

▪ Assist the RAO with the study set-up activities, submission and amendment of documents package to the Ethics Committees and Regulatory Authorities▪ Prepare and maintain the Trial Master File, the Site Investigator File and the Pharmacy File according to SOPs and GCP▪ Support study monitoring and CRO, in accordance with company SOPs and theICH GCP guidelines▪ Collect, review and track clinical study documents (financial agreement, IP’s documentation) and manage study material shipments to the site▪ Archiving

Londra, Regno Unito

Molecular cell Biology project: "Mechanism of pseudohypoxia induced loss of primary cilia in pheochromocytoma."- STATISTICAL BIOINFORMATICS and TRANSCRIPTOMIC ANALYSIS: comparision of gene expression in normal and tumor tissue, using software including GraphPad and the digital platform PubMed- DATA ANALYSIS TECHNIQUES: statistical normalization methods- CELL COLTURE: mainteinance of cell colture and cell counting learning the use of C-Chip Haemocytometer- DNA AMPLIFICATION: PCR and RT-qPCR in order to detect differences in transcript levels of normal and tumor tissue- RNA INTERFERENCE: siRNA mediated knockdown in order to inhibit gene expression or traslation- mRNA ISOLATION and REVERSE TRANSCRIPTION: Synthesis of the cDNA-IMMUNOCYTOCHEMISTRY, IMMUNOFLUORESCENT LABELLING and CONFOCAL MICROSCOPE: in order to confirm the expression and location of target protein antigens in the cell-IMMUNOBLOTTING, SDS-PAGE: extraction, immunoprecipitation and electrophoretic separation of proteins in order to quantify and compare levels of specific proteins in normal and cancer tissueWith my research I contributed to the publication of the article:"Oncometabolite induced primary cilia loss in pheochromocytoma", Endocr Relat Cancer, 2019 Jan.

Firenze, Italia

-Teaching Assistance for students in Math, Physics and Biology-Management and Organization of a help desk for the recovery of learning gaps-Management of BSc students, helping them preparing their thesis-Management of a digital platform-Management of administrative practices- Public Relations: Communication with students and professors, Monitoring of the university website, creation of a mailing list. Management of the official tutoring social media, Advertising and Public Speaking. Planning, organization and management of scientific events -Problem Solving

Firenze, Italia

Nutritional Epidemiology project: Estimation of the level of Adherence to the Mediterranean Diet in a group of Italian high school students in relation to their lifestyles, social and family contexts. -USE OF STATISTICAL TOOLS TO EVALUATE NUTRITIONAL ABITS-STATISTICAL BIOINFORMATICS NUTRITIONAL ANALYSIS-DETECTING OF PUBLIC HEALTH POLICIESWith my research I contributed to the publication of the article: "Adherence to the Mediterranean diet in a sample of Tuscan adolescents", Nutrition, 2014.

Msc, Biomedical Biology, 110 Cum Laude /110

Bsc, Biological Sciences, 101/110