La Faculty Completa




Luana Riccardi

Regulatory Affairs & Safety Manager
  • 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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