Francesca Cupellaro Email & Phone Number

Roma

I worked as regulatory product lead of an orphan drug. Management of new registration procedures in different countries in the world (outside EU) as regulatory product lead. Lifecycle management of the MA already approved in EU (centralized procedure) and in other countries like US, Canada, Australia, Argentina and Switzerland. Submission and management of new MAA in Switzerland according to art.13 TPA. Lifecycle management of product registered in CH.

Roma, Lazio, Italia

In this experience, I was responsible for two main registration projects: submission of MAA through MRP and DCP procedure in Europe by a new Pharmaceutical Company. I identified all the nationals requirements to comply for RMS and CMSs. I also coordinated the projects involving the main responsible people from PhV, QA and Medical department with the aim to handle all the activities needed (eudravigilance registration, appointment of local contact point, PSMF, QA and PhV agreements ect) and to share all the information needed for the submission. At the very end of my experience I also attended to Aifa inspection for service provider as responsible for regulatory activities. I handled the interview without problems and the final outcome was positive.

Roma, Italia

During this experience, I supported different clients as senior consultant in different projects. I performed due diligences with the aim to provide a clear overview of the registration status of a product, needed for acquisition of the MA from future MAH. I also was responsible for reviewing module 3 and the dossier according to the main EMA and ICH guidelines. I also supported the clients preparing specific expertises to evaluate the possibility to extend therapeutic indications.As important experience, I worked on the preparation of MA as national application only (IT) and I also managed the Aifa requests. For this MAA, I also prepared the PIP waiver application for the submission to EMA which was successfully approved.

Roma, Italia

During this experience, I supported different clients preparing the submission of variations to the Italian Health Authority (Aifa). I usually worked with the CMC department and the regulatory teams of the manufacturers to collect the documents needed for quality changes. I also checked the promotional materials for the submission to the Ministry of Health.

Cisterna Di Latina

durante il periodo di tirocinio ho imparato diverse funzioni:- funzionamento sistema WinFarm- dispensazione dei medicinali- gestione di farmaci stupefacenti - gestione del magazzino - gestione ordini- gestione resi- gestione/dispensazione medicinali DCP- gestione piano terapeutico - gestione dei medicinali scaduti- preparazione estemporanea di prodotti magistrali

Master'S Degree, Management E Marketing Dell’Industria Farmaceutica

Corso Alta Formazione Affari Regolatori

Farmacia, Farmacia

Diploma Liceo Scientifico, Liceo Scientifico Ordinario