Legal Guidance and Research / Experts / Vincenzo Salvatore
Vincenzo Salvatore#3983
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Prof Vincenzo Salvatore

Simmons & Simmons
I have been a qualified Italian lawyer since 1991 and hold the position of full professor of EU Law at the University of Insubria, Varese (Italy), where I also instruct on International Trade Law. 

Currently I am a Partner at Simmons & Simmons. Prior to this, I have served as the Head of the Healthcare and Life sciences practice at BonelliErede law firm in Milan. Before that, I spent three years with Sidley Austin LLP’s global life sciences team. My career journey includes a significant tenure at the European Medicines Agency, where I served as the Head of the Legal Service from 2004 to 2012 and as the Data Protection Officer from 2005 to 2011.

I provide regular counsel to pharmaceutical companies, medical devices manufacturers, and the food and cosmetic industry on a wide range of regulatory matters related to their operations. Furthermore, I have a proven track record of representing these clients before the high courts in Italy, the Court of Justice of the European Union, and in arbitration proceedings. My expertise is in high demand, often leading to invitations to speak at international conferences and conduct training sessions at corporate offices. 

I have authored a dozen books and contributed to over fifty articles published in esteemed law journals. As a native Italian, I am proficient in English and fluent in French and Spanish.  

Practice Area

Panel

  • Contributing Author

Qualified Year

  • 1991 (Italian qualified lawyer)

Experience

  • European Medicines Agency (2004 - 2012)
  • Sidley Austin LLP (2012 - 2015)
  • Studio Legale BonelliErede (2015 - 2024)

Membership

  • AISDUE (Associazione italiana di studiosi dil diritto europeo – Italian Society of European Union Law scholars)

Qualifications

  • Degree in law (Laurea in giurisprudenza) (1986 (with hons))
  • Phd in Law (1991)

Education

  • University of Pavia (Italy) (1982-1986 )
  • European University Institute (Florence) (1987-1990)

1 Contributions by Vincenzo Salvatore

EU transparency and access to medicinal product information: EMA/CTIS publication regimes, EPARs, CCI/PPD protections, access and appeal procedures, and leading case law
PRACTICE NOTES
EU transparency and access to medicinal product information: EMA/CTIS publication regimes, EPARs, CCI/PPD protections, access and appeal procedures, and leading case law
In recent years, interest in information on medicines has risen steadily among a wide range of stakeholders, including the general public, patient associations, physicians, the pharmaceutical industry and academia. In response, legislators and medicines regulators have embraced a more open stance, enabling access to a broader set of documents and data on the quality, safety and efficacy of medicinal products than at any time before. Within the EU, the European Medicines Agency (EMA) is the authority charged with protecting and promoting human and animal health. Among the EMA’s core duties are the scientific assessment of applications for marketing authorisation (MA) via the centralised procedure, and the co-ordination of the EU pharmacovigilance system to monitor the safety of medicinal products. Consequently, the EMA holds extensive scientific and clinical data on medicines. There are multiple channels through which documents and information on medicinal products can be accessed...
Life Sciences
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