La Faculty Completa




Luana Riccardi

Regulatory Strategy Associate Director in Vertex Pharmaceuticals Italy

Laurata in Chimica, inizio a lavorare in Novo Nordisk come prima esperienza in un'azienda farmaceutica nel 2006. Inizio il mio percorso come Medical Advisor per poi passare al mondo del Regolatorio e della Farmacovigilanza fino a diventare responsabile del dipartimento per l'Italia e Malta. Dopo 14 anni decido di intraprendere un nuovo percorso ed entrare a far parte dell'organico della Vertex Pharmaceuticals in Italia.

Le responsabilità rimangono sempre legare al Regolatorio, ambito che non saprei più lasciare proprio per la caratteristica di abbracciare l'azienda a 360°.

  • Regulatory Affairs & Safety Manager

    • Regulatory activity management for Italy and Malta:
    • Translating product information (SPC, PIL, Label, Carton);
    • Proof-reading of packaging materials ;
    • Supporting product file submission to HA;
    • Providing regulatory approval of promotional activities/material ;
    • Supporting Regulatory Budget;
    • Update of local regulatory SOPs ;
    • Updating on regulatory and safety legislation;
    • Supporting QAP forecast and monitoring;
    • Responsible for Safety and Pharmacovigilance:
    • Pharmacovigilance activity management ;
    • Customer Complaint activity management;
    • Update of local safety SOPs;
    • Training NNI personnel on compliance of Italian regulatory environment
    ;

  • Regulatory Affairs Specialist

    • Support in Regulatory activity management for Italy and Malta:
    • Translating product information (SPC, PIL, Label, Carton);
    • Proof-reading of packaging materials ;
    • Supporting product file submission to HA;
    • Update of local regulatory SOPs ;
    • Updating on regulatory and safety legislation;
    • Support in Safety and Pharmacovigilance activities
    ;

  • Regulatory & Medical Affairs Officer

  • Medical Advisor

    Reporting to the Local Trial Manager, handling of start-up documentation and monitoring of clinical trials especially for observational studies;
    Management of medical records related to drugs in accordance with SOPs, GCP and ICH;
    contacts with KOLs for the initiation phase, operation and final reports of clinical trials;
    updating and reporting of clinical research activities;
    scientific support for the product specialists and Marketing Department.

 

 

 

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