Elena Marzano

- Lifecycle Management of medicinal products authorized by national, DCP/MRP, Centralized procedures (new MAs, type I-II variations; renewals; end of procedure communications, OJ publications; National databases and Farmastampati Service);

- Revision and updating of national texts (SmPC, PL, Labeling), Educational Materials and FIT cards;

- Revision and approval of national artworks;

- Revision and management of promotional materials;

- Administration of regulatory activities via AIFA Front End portal (Conferences and Meetings management; POL management);

- Monitoring of local medical literature;

- Management of reports related to ADRs and Product Complaints;

- Performed and documented quality control checks to maintain compliance with company initiatives;

- Facilitated productive communication between company management and regulatory agencies, fostering positive relationships;

- Maintained detailed records of all regulatory activities, enabling quick access during inspections or audits;

- Support and collaboration with colleagues in managing assigned tasks;

- Autonomous execution of assigned activities;

- Carrying out assigned tasks with attention and precision.

- Lifecycle Management of medicinal products authorized by national, DCP/MRP, Centralized procedures (new MAs, type I-II variations; renewals; end of procedure communications, OJ publications; National databases and Farmastampati Service);

- Revision and updating of national texts (SmPC, PL, Labeling), Educational Materials and FIT cards;

- Revision and approval of national artworks;

- Revision and management of promotional materials;

- Administration of regulatory activities via AIFA Front End portal (Conferences and Meetings management; POL management);

- Monitoring of local medical literature.

- Management of reports related to ADRs and Product Complaints.

Regulatory activities support: preparation and management of MA variations relating to medicinal products for human use (type I-II variations; renewals; end of procedure communications; OJ publications; MAH transfers); revision and updating of texts, artworks and FIT cards; management of regulatory activities via AIFA Front End portal (Conferences and Meetings management; POL management);