Chiara is a regulatory specialist and a patent litigator with a specific focus in the Life Sciences sector.
Chiara is an associate in the Life Sciences team of the Milan office.
She focuses on EU and national regulatory and patent, SPC and general IP matters relating to medicinal products, medical devices and other regulated products. Her practice covers strategic advice on regulatory, commercial and compliance matters, patent and SPC litigation, and contract drafting and negotiation.
Chiara deals on a daily basis with both international and Italian companies that are looking at developing their business in the European Union.
Chiara co-authored the Report titled “EU SPC manufacturing waiver becomes effective: what can industry expect” published on the European Pharmaceutical Law Review, Vol. III, of 2019.
Background
Chiara is a qualified lawyer admitted to the Milan Bar. Prior to joining Herbert Smith Freehills, Chiara worked for a major international law firm.
She graduated with honours at Università degli Studi di Milano and she obtained her law degree after attending semesters of studying at Cornell Law School (New York) and Université de Reims Champagne-Ardenne (France).
Experience & expertise
Selected matters
- Seconded to Advanced Accelerator Applications, a Novartis company, in Geneva for four months, where she gained specific experience in matters concerning promotional activities by the pharmaceutical industry and their interactions with healthcare professionals.*
- Advised a major US-based biopharmaceutical company in the development of a compliance program and revision of their standard operating procedures related to interactions with healthcare professionals in 47 jurisdictions worldwide. She contributed to the drafting of the Italian compliance policy and coordinated the advice from the remaining jurisdictions.*
- Supported a global player in the pharmaceutical market in a matter relating to the potential violation of data exclusivity and market protection enjoyed by the company’s medicinal product by some generic companies. Chiara assisted the client in the filing of a freedom of information request with the Italian Medicine Agency to gain access to the generic companies’ marketing authorization dossiers and handled the relationship with the Agency in the course of the procedure.*
- Provided regulatory advice on the transfer of marketing authorizations and related contractual arrangements to a major pharma client in the context of a complex M&A transaction.*
- Provided guidance to a leading EU-based pharmaceutical corporation on data exclusivity rules under EU pharmaceutical legislation with a view to assessing the implications and providing strategic advice in the context of a major business transaction.*
*Prior to joining Herbert Smith Freehills
Sectors
Services
