Elisa Finotti

Regulatory Affairs @Abc Farmaceutici Spa

Ivrea, IT

preparation, follow-up & post-approval activities of regulatory variations (submission to AIFA in NP | DCP & MRP)• focus on safety variation procedures (SmPC | PL | Labelling) in compliance with National and EU regulations and guidelines (QRD template | Excipients and information for the package leaflet | Pharmacovigilance inputs)• variations type IA, IB & article 5 (Guideline of Commission Regulation (EC) No 1234/2008)• technical documents: Cover letter | eAF | CTD module 1 & module 3• eCTD system and Lorenz Validator• administrative procedure (Front End | POL | publishing in GU | Farmastampati)• managing communications with AIFA• post-approval variation (quality & safety) communications to customers in the EU & extra-EU and preparation of documents required by the country\'s Competent Authority for submission (CEP update, added batch size, PIL/SPC variation)• renewal procedures in the EU & extra-EU (FSC-CPP | CTD module 3 compliance | Addendum Quality Overall Summary | ICH Quality Guidelines | PIL/SPC/AWs | proforma WS-FP) • new-registration in EU & extra-EU and management of DL • documents for CPP with AIC & CPP-CLV without AIC • artworks PIL/Pack/Label/blister for EU & extra-EU customers • knowledge of the ASEAN guideline