Noemi Cirelli Email & Phone Number

Bologna, It

Pomezia, Lazio, Italia

- Product Dossier (PTD, PIF, Technical Document) updates in line with Regulatory Authorities requests, formulation changes, or new requirements coming from manufacturing sites- Notification of new Non-Pharma products (NSIS, CPNP)- Interaction with National Competent Authorities- Regulatory intelligence for Non-Pharma products, from development to placing on the market- Transition to MDR and IVDR, compliance to new regulatory requirements- Review and approval of advertising and promotional materials - SOP revision- Regulatory support to Italian CMOs- Systems and procedure packs

Roma, Lazio, Italia

- Review of medical devices promotional materials in accordance with local regulatory requirements (D.Lgs. 219/2006, Guidelines); use of Veeva Vault PromoMats- Review of promotional materials on over-the-counter medicinal products for healthcare professionals- Review of translated materials - Preparation of tender documentation- Regulatory compliance and local submission to AIFA and Ministry of Health to obtain authorization for the dissemination of advertising material- Regulatory surveillance: regulatory monitoring of main Health Authorities’ Institutional website

Siena, Toscana, Italia

- Support in writing and preparing technical documentation for registration of the company's IVD devices in non-EU countries; submission to local Ministries of Health- Study of current IVD Regulation (IVDR) and IVD Directive- Audit observer on MDSAP program

Fano, Marche, Italia

- Listening and counseling; sales to the public- Personal services (blood pressure measurement, COVID-19 swabs)- Inventory management and verification of purchase, return, and sales documentation - Updating mandatory records and checking product expiration dates

Laurea Magistrale A Ciclo Unico, Chimica E Tecnologia Farmaceutiche, 96/110

I did an experimental thesis in Organic Chemistry. The work was on synthesizing, purifying, and identifying structural analogues.

Master Universitario Di 2° Livello, Gestione Regolatoria Del Ciclo Di Vita Del Farmaco

- CTD, D.Lgs. 219/2006, EudraLex, ICH, Registration procedures, variations, renewals, Sunset Clauses, management and negotiation of prices.

Pharmacovigilance Theoretical-Practical Training Course

- Pharmacovigilance history and regulations, PV in Clinical Trials and post-marketing, GVP and GCP - Identification and management.

Abilitazione Alla Professione Di Farmacista

License to practice as a pharmacist

Diploma Di Liceo Linguistico, 86/100

Languages studied: English, French, German