Chiara Nardoni Email & Phone Number

Rome, It

Roma, Lazio, Italia

Roma, Lazio, Italia

Preparation and management of MAs transfer dossier for Bayer dermatological portfolio to LEO Pharma, collaborating with HA and internal depts such as FVG, QA, distribution and marketing, taking care also of regulatory activities related to the manufacturing site (new manufacturing license, CPP requests, AWs regulatory review). Maintenance of drug products, responsible for submission and approval of renewals, minor and major variations (both technical and having impact on PI), together with deficiency letters and relevant sunset clause.Regulatory review of Promotional materials and cross functional support for the launch of new products.Management of dear doctor letter (DHPC, NII) and ban of sales, followed by product recall procedure.Interaction with HA (in particular with AIFA) and international stakeholders for many kind of requests.

Roma, Italia

Tailored support to customer in:- Collection, preparation and review of required documents for submission of variations (administrative and quality changes) for drug products registered under NP, MRP and DCP. Update of CTD sections (Module 3) and finalizing of variation package.Regulatory activities for MA submission and license maintenance in accordance with Authority’s commitments, regulation and guidelines.Preparation and management of documentation required for drug product MAH transfer.- Setting up of technical gap analysis for CMC Regulatory Compliance projects. Comparison between registered dossier and manufacturing site documents finalized to technology transfer projects but also for Module 3 baseline reconstitution; evaluation of the regulatory impact and proposal of appropriate strategies.

Basel Area, Svizzera

Design and implementation of mechanistic in vitro/ex vivo investigations for dissecting mechanisms of drug toxicity or characterizing therapeutic target-related safety concerns, using variety of molecular, biochemical and cellular biology methods.

Roma, Italia

Investigation of MyoD gene's role in DNA damage and repair processes developed in senescent cells. Pervasive analysis of its function in distrophy and progeria syndrome.

Roma, Italia

Characterization of the role of MyoD, master gene of muscle differentiation, in DNA damage and repair. Genome-wide approaches and implications in muscle pathologies like distrophy, atrophy and progeria syndrome.

2Nd Level Master, Discipline Regolatorie E Politica Del Farmaco

Activities and Societies: Titolo della tesi: "Line extensions come strumento di prolungamento del lifecycle di un farmaco. Gestione.

Master'S Degree, Biotecnologie Mediche, 110/110 E Lode

Activities and Societies: Tirocinio formativo della durata di due anni e 6 mesi nel laboratorio di Farmacologia epigenetica del Dott. Pier.

Laurea, Biotecnologie, 110/110 E Lode

Laurea con lode. Titolo della tesi: "Utilizzo della Chromatin Immunoprecipitation per determinare il ruolo della histone-demetilasi Jhd2.

Maturità Scientifica, 100/100

Activities and Societies: Trinity college Grade 5, patente ECDL. Lezioni di piano (5 anni), coro (soprano), atletica leggera (salto.