Legal, regulatory & ELSI partner (health law and emerging technologies)

I am a Tenure-Track Assistant Professor of Comparative Private Law at Sant’Anna School of Advanced Studies (Pisa, Italy), affiliated with the DIRPOLIS Institute, the LIDER Lab and the Interdisciplinary Health Science Center.

I am a legal scholar and conduct academic legal research. I am looking for consortia that need a research partner mainly for the legal, ethical and societal dimensions of the following topics:

• HORIZON-HLTH-2027-03-TOOL-08 – Towards the next generation of frontier Artificial Intelligence models for healthcare

• HORIZON-HLTH-2027-01-CARE-02 – Personalised approaches to reduce risks from Adverse Drug Reactions due to multiple medications

• HORIZON-HLTH-2027-02-TOOL-01-two-stage – Predictive biomarkers of disease progression and treatment response using AI methodologies for chronic non-communicable diseases

Research I can contribute

• Comparative and EU legal analysis of the regulation of medicines and medical devices (including the pharmaceutical and MDR/IVDR reforms), off-label use and pharmacovigilance

• Research on civil and product liability for medicines and AI-driven medical devices (revised Product Liability Directive)

• Legal analysis of how the AI Act and the MDR apply to AI-based decision-support tools and continuously learning AI medical devices

• Research on health data governance: GDPR, European Health Data Space, biobanks, consent models and secondary use of data

• ELSI work packages, stakeholder engagement, policy recommendations and training

• Dissemination, summer schools and capacity building

This research can inform a project's regulatory strategy, but I do not provide compliance assessments or certification support.

Relevant experience

• PI of the Jean Monnet Module PERSONA, “Law for Personalising Medicine in the EU” (2025–present)

• Former Marie Skłodowska-Curie Individual Fellow (FullCompensation, Maastricht University) and former postdoctoral legal researcher in H2020, Nordforsk and regional projects on health data and biobanking (ENLIGHTENme, CG, CHRIS-2D)

• Author of The Law of Off-label Uses of Medicines (Routledge, 2022) and of numerous peer-reviewed articles on medicines regulation, AI-powered medical devices, data sharing and the EHDS

For further details, see my CV in the uploeaded files.

What I am looking for
I am interested in joining as a partner or work package leader for the legal, ethical, and policy-oriented research tasks, from proposal writing through implementation