As Counsel in our Milan and Rome offices and a member of our International Life Sciences and Intellectual Property groups, I have a longstanding reputation as an expert in both the regulatory and IP aspects of life sciences.

With over 15 years' experience advising clients across life sciences, I offer legal advice on medicinal products, medical devices, food supplements, cosmetics, plant protection products and in relation to regulatory, IP issues and commercial issues. I help our leading clients manage product classification issues, R&D and clinical trial matters, authorisation/registration/certification procedures, RDP issues, market access issues, including early access programmes, price and reimbursement issues. I also advise on pharmacovigilance/materiovigilance, compliance, including advertising and interaction with HCPs, HCO, Patient and Scientific associations, and all the relevant commercial agreements.

Before joining Bird & Bird in 2008, I spent several years working for medicines authorities including the Italian Ministry of Health, the Italian Medicines Agency (AIFA) and the European Medicines Agency (EMA). In particular, during my time at the EMA, I was responsible for all legal matters relating to IP protection and innovation development.

I provided legal support to the Paediatric Committee (PDCO) and the Name Review Group (NRG) and also contributed to the Advanced Therapy Regulation implementation. I was responsible for providing a full range of pharmaceuticals advice, including on generics and data exclusivity issues, biosimilars, parallel import and parallel distribution issues, orphan drugs, SMEs and transparency issues. I was also a member of the EMA Innovation Task Force, which specialised in product classification and borderline issues.

I am fluent in English, French, Spanish and Portuguese in addition to my native Italian, in which I often speak and write on matters in life sciences and IP.

  • Over the years, I have developed particular experience in complex regulatory issues (contentious and non-contentious) including market access issues, such as price and reimbursement negotiations, MAEs, measures for the containment of the NHS expenditure (i.e. claw back/payback) and compliance. I have advised our clients operating mainly in the life sciences sector in complex deals involving the assignment or acquisition of relevant assets, in research and development activities, in compliance issues including investigations and trainings.
  • Advised a client on a complex litigation concerning reference pricing established by Italian government authorities.
  • Advised a client in the exploitation of biological samples and relevant information, in the establishing of a disease register and master cell banks.
  • Advised clients in complex pharmaceutical-regulatory controversies concerning fixed dose combination products involving regulatory data protection issues, as well as substitution between medicines issues.
  • Advised clients in criminal proceeding cases concerning the compliance with rules on promotion of medicinal products, interaction with HCPs, support of no-profit clinical trials.
  • Advised clients on issues concerning manufacturing of cannabis and industrial products containing the same, classification of products containing cannabis, tenders for the supply of cannabis to the Italian NHS.
  • Advised clients on the marketing of products containing GMOs.
  • Advised clients on the classification, marketing and use of e-health products, including medical Apps.
Education
  • Università di Bologna, Law, IP law, EU and International law
Admissions
  • Consiglio Dell'Ordine Degli Avvocati E Procuratori Di Roma (Council of the Bar Association of Rome) in 2005