Ilaria De Luca Email & Phone Number

Rome, It

Roma, Lazio, Italia

Pulmonary Hypertension #raredisease (Key Customers: #Cardiologist ) - Immunology Rheuma & Gastro

Roma, Lazio, Italia

Roma

Roma, Italia

Immunology (Remicade & Simponi)

Parma, Italia

Main daily activities : - Management of complaints from international and national markets; - Batch record review for approval of new batch and to ensure the GMP; - Meeting with QA , QP , production team , CAPA team.I'm QA Specialist and I work to ensure compliance ( Product Compliance ) and the Release of products such as drugs, medical devices and biological products for respiratory diseases .SKILLS: GMP,SOP, SAP, Trackwise, Batch Record Review activity and approval process of new lots, understanding the flow of activities in the production process and after-sales, international claims management and preparation of periodic Product Quality Reviews (PQR), problem solving, CAPA plan, production process.

Bologna, Italia; Catanzaro,Italia

Clinical Data Manager/Study Coordinator (in the team of Prof. Giovanni Martinelli) at Institute of Hematology "Seràgnoli"​ and then at Hospital "Pugliese-Ciaccio".The training allows to support and collaborate with the already consolidated core of researchers, Study Coordinator, Data Manager and Clinical Monitor.I can apply what I learned in the course on Clinical Research.SKILLS: management of a clinical study with analysis of study protocols and procedures ethical and regulatory; consultation essential documents; participation in SIV, monitoring and COV; compilation eCRF and processing and shipping samples, regulatory knowledge including GCP; meet needs monitor and principal investigator; problem solving and time management.

Emilia Romagna

Salveo & Genoma: Training, Consulting, marketing and sale of services as:- storage of hematopoietic stem cells derived from umbilical cord blood, and mesenchymal stem cells contained in umbilical cord tissue and useful for regenerative medicine;-Predictive medicine: acquisition of knowledges about to test pre and postnatal care as non-invasive prenatal testing (NIPT that uses the method of "next generation sequencing" of fetal DNA circulating in maternal blood) for identifying chromosomal alterations,various syndromes,early identification of metabolic disorders or a predisposition to allergies.The activity was developed in collaboration with gynecologists, midwives, PMA centers, analysis laboratories, pharmacies and drugstores.Skills:marketing plan, market analysis and competitor analysis, negotiation, training on the service offered to doctors and patients; management time,problem solving, visits and trips; oral and written communication skills; understanding policy of the multinationals.Scientific SKILLS:regenerative medicine, stem cells, predictive medicine, prenatal, neonatal, non-invasive prenatal test.

Torino, Italia

Trainee in:-process of development of a drug with analysis primarily of pre-clinical and clinical stages and regulations required to obtain the marketing authorization AIC;-Business Development,Marketing and Outsourcing advantages in R&D and strategic partnerships Sponsor-CRO and analysis of the criteria for selection of Service Providers CRO. In collaboration with ABLE Biosciences (CRO).I interviewed the directors of Sponsor important to understand their needs and what they want to get from a CRO to have a strategic partnership and functional.Analysis of the process of drug development from discovery to Phase IV and analysis of the main standards required by GLP, GCP, GMP.Analysis of the elements which give rise to a CRO among competitors as Marketing and Business Development.SKILLS: Business Development, Marketing, Outsourcing, Sponsor, CRO, Preclinical and Clinical Stages, Linear Wight Metod, Interview

Ottimo 10/10

• Gli affari regolatori; • La farmacovigilanza: controllo e sorveglianza dei farmaci; • Monitoraggio dei processi e controllo qualità.

Missione Cra, 40H Course In Clinical Research In Compliance With The Ministerial Decree 15.11.2011, Coordinatore Ricerca Clinica

1. Methodology and regulation of clinical trials; 2. Good Clinical Practice (GCP); 3. Rules of Good Manufacturing Practice (GMP).

Master'S Degree In Medical Biotechnology, Medicine (110 Cum Laude And Right To Publish), Biotecnologie Mediche, 110 Cum Laude And Right To Publish

Activities and Societies: Dissertation consists of two parts : 1 ) process of development of a drug with analysis primarily.

Degree In Biotechnology, Biotecnologie

Title of Dissertation: Nesfatin-1 as a new cardiac peptide. Prof. T.Angelone, September 2012, Unical.