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Bio

Andrea è Ricercatore in Tenure-Track (RTT) in Diritto Privato Comparato presso la Scuola Superiore Sant'Anna (Pisa, Italia).

In precedenza, è stato Assistant Professor di Health Law presso il dipartimento di Health, Ethics and Society (HES) della Faculty of Health, Medicine and Life Sciences (FHML) presso l'Università di Maastricht. Presso tale università è stato Marie Skłodowska-Curie Fellow presso l'Institute for Transnational Legal Research (METRO) della Faculty of Law, dove ha implementato la sua fellowship MSCA, finanziata dall'UE, "FullCompensation" (grant agreement n. 101028723).

Dal 2020 al 2024, Andrea è stato anche docente a contratto di Markets, regulations and Law presso l'Università Luiss Guido Carli (Roma, Italia).

Ha conseguito il dottorato di ricerca in Persona e tutele giuridiche presso la Scuola Superiore Sant'Anna nel 2019, con una tesi sui profili di responsabilità civile e regolazione nel mercato europeo degli usi non autorizzati di farmaci. A partire dalla sua tesi di dottorato ha redatto la monografia di ricerca "The Law of Off-label Uses of Medicines: Regulation and Litigation in the EU, UK and USA", pubblicata da Routledge nel 2022 (https://www.routledge.com/The-Law-of-Off-label-Uses-of-Medicines-Regulation-and-Litigation-in-the/Parziale/p/book/9781032078984).

Durante il suo programma di dottorato, ha condotto dei periodi di ricerca presso l'Ecole Normale Superieure e l'Université Paris 1 Panthéon-Sorbonne (Parigi, Francia). Ha inoltre rafforzato le sue competenze di ricerca in diritto, salute e politica presso l'Ufficio europeo per gli investimenti per la salute e lo sviluppo dell'Organizzazione Mondiale della Sanità (Venezia, Italia).

Parallelamente alla sua attività di ricerca, Andrea ha collaborato con studi legali in Milano e Roma.

Parla italiano, inglese e francese.

Ricerca

I suoi principali interessi di ricerca includono:

1. Responsabilità civile, in particolare responsabilità medica e da prodotto difettoso.

2. Diritto e salute, con particolare riguardo alla regolamentazione farmaceutica e dei dispositivi medici, i profili giuridici della sperimentazione clinica, nonché le implicazioni giuridiche della condivisione di dati sanitari e genetici per la ricerca, che ha ricercato e implementato in termini di politiche di accesso presso la biobanca dell'Istituto di Biomedicina Eurac Research (Bolzano, Italia), in qualità di ricercatore post-doc presso tale istituto.

Approfondisce e diffonde i risultati della sua ricerca tramite pubblicazioni scientifiche, presentazioni a conferenze internazionali e iniziative di advocacy.

Coinvolgimento in progetti di ricerca:

2023-Present: BRIEF – Biorobotics Research and Innovation Engineering Facilities, member of the Advisory Board of the Law and Policy Hub.

2022-2023: FullCompensation – Rationalising Full Compensation of Non-Pecuniary Damages to Reconcile Equal Treatment and Personalisation, Marie Curie Individual Fellowship (GA 101028723).

2021-2022: CG – Research Towards Improving the Governance of Health Data in Cyberspace (Nordforsk fund).

2021-2022: ENLIGHTENme – Innovative policies for improving citizens’ health and wellbeing addressing indoor and outdoor lighting (Horizon 2020 GA No 945238).

2021-2022: CHRIS-2D - A Dynamic Data infrastructure for biomedical research and innovation in South Tyrol (EFRE 2020)

2020: OPT-HepaC - Optimisation of diagnosis and care Pathways for chronic HCV in Tuscany (Bando Ricerca Salute Regione Toscana 2018).

2019-Present: ETHOS - EThics & law witH and fOr research (LIDER Lab, Sant’Anna School of Advanced Studies).

2015-Present: Osservatorio permanente sul danno alla persona, funded by IVAS.

2018: Accesso ai farmaci: il caso e ruolo dell'Italia (Oxfam Italia and Action – Global Health Advocacy Partnership).

2016: Stampa 3D, Fab Labs e la nuova “rivoluzione industriale” Profili di proprietà intellettuale e responsabilità per danno da prodotti difettosi (partnership between Associazione per l’Istituzione della Libera Università Nuorese (AILUN) and Sant’Anna School of Advanced Studies).

2015-2017: AREYOUFINE?: Training in assessment of personal injury based on biomechanical analysis to improve the sustainability and efficacy of the health care system. Strategic Partnerships in the field of education, training and youth – Erasmus Plus 2015, European Commission H2020. Project Coordinator: Instituto de Biomecánica de Valencia (IBV).

2015-2016: Droit – Droni in Toscana. Partnership between Istituto di Teoria e Tecniche dell’Informazione Giuridica (ITTIG), Florence and Dirpolis Institute of Sant’Anna School of Advanced Studies, Pisa. Funded by Fondazione Ente Cassa di Risparmio di Firenze.

Pubblicazioni

Corsi

Invited speaker

Discussion panel of the Advisory Board of the Law and Policy Hub at the Biorobotics Research and Innovation Engineering Facilities: Scenari di ricerca e d’innovazione conference held at Sant’Anna School of Advanced Studies (Pisa, 5 March 2024)

Rationalising full compensation of non-pecuniary damages to reconcile equal treatment and personalisation: Results from the EU project Full Compensation, presentation given at the European Society of Empirical Legal Studies (ESELS) Conference at Warsaw School of Economics (Warsaw, 26 September 2023)

L’entrata in vigore di CTR e MDR: le ricadute applicative, lecture given within the course Aggiornamenti in materia di GDPR, CTR, MDR: protezione dei dati, sperimentazioni cliniche a scopo di ricerca scientifica, dispositivi medici. Supporto giuridico alla ricerca, sviluppo e innovazione, held at Sant’Anna School of Advanced Studies (Pisa, 8 June 2023)

Le linee guida in materia di personalizzazione del danno, presentation given at the conference Scienza dei dati al servizio del giurista: verso un Osservatorio sulla giustizia civile a Pisa, held at Sant’Anna School of Advanced Studies (Pisa, 19 May 2023)

Biobanche e ricerca biomedica nell’UE: tra condivisione e protezione dei dati, lecture given within the course Diritto UE dei dati e delle tecnologie. Corso di Diritto e Tecnologia at Padua University (Padua, 15 May 2023)

Regulating Off-Label Uses of Medicines: From Soft Law to Civil Liability, and Beyond, presentation given at the workshop Liability and Insurance Self-Regulation and Soft Law as Grounds for Liability? at the Ius Commune Conference Maastricht 2023 (Maastricht, 12 May 2023)

Off-label uses of medicines: civil liability and no-fault under conditions of scientific uncertainty, presentation given within the European Doctorate of Law & Economics (EDLE) at Erasmus University Rotterdam (Rotterdam, 17 January 2023).

Ethical and Legal Issues in Accessing Biobank Data to develop AI tools, presentation given at the conference Designing Human Rights Attentive AI – An Interdisciplinary Perspective organized by the EU-funded project LeADS (GA ID: 956562) and the LIDER-Lab of Sant’Anna School of Advanced Studies (Krakow, 21 September 2022).

Legal complexities in making data available for research, presentation given within the panel The CHRIS Study: 10 years of dynamic consent as part of a participant centric approach to the governance of samples & data at the World Congress of Bioethics (Basel, 22 July 2022)

Covid-19 off-label uses of medicines: the role of civil liability, presentation given at the Pandemics – Liability and Insurance organised by the European Centre of Tort and Insurance Law (ECTIL) (Vienna, 23 June 2022)

Ethical legal issues for patients: frontiers of biomedical research, presentation given within the Transitional (Legal) Times for R&D and R&I Sectors panel at the Computers, Privacy and Data Protection conference CPDP 2022 (Bruxelles, 25 May 2022)

Research on Health and Urban Lighting Between Open Data and Data Protection, online presentation given at ENLIGHTENme project conference (17 December 2021)

Assisted Reproduction: The ECHR's cases, lesson given within “Biolaw and biomedicine regulation” course organized by European Public Law Organisation (EPLO, Athens) (26 November 2021)

Appropriate safeguards under Article 89 GDPR in research biobanks, online presentation given at Biodata 2021 confrence organized by BBMRI (26 November 2021)

Sperimentazioni cliniche e protezione dei dati personali: il nuovo regolamento Clinical Trials Regulation, webinar delivered within the webinar series on Health Law, Privacy, and Family Rights organised by Sant’Anna School of Advanced Studies and Associazione Libera Università Nuorese (AILUN) (12 November 2021).

Safeguards & responsibilities in biobank, databank and genetic research, online presentation given with Deborah Mascalzoni and Ciara Staunton at GenoPri 2021 online conference organized by Yale University (22 September 2021)

Una panoramica delle novità introdotte dal Clinical Trial Regulation, Parte I e II, lessons within the course “Orientarsi tra GDPR e CTR: protezione dei dati, sperimentazioni cliniche a scopo di ricerca scientifica. Supporto giuridico alla ricerca, sviluppo e innovazione” held at Sant’Anna School of Advanced Studies (Pisa, 8 and 15 September 2021)

Orphan drugs: legal rules and economics, lesson within the “Pharmaceutical markets and regulation” LUISS-Italian Medicines Agency joint course (21 April 2021, Rome)

Le responsabilità civili nell'uso e nella gestione dei fablab, webinar delivered within the online training program of Associazione Libera Università Nuorese (AILUN) in collaboration with Sant’Anna School of Advanced Studies (12 November 2020).

Orphan drugs’ prices: regulatory and competition law implications, presentation given within the course “Markets, regulation and law” at LUISS Guido Carli University – Department of Business and Management (14 November 2018, Rome).

Politiche per l’accesso ai farmaci in Italia, presentation given within the “Seminari scuola di specializzazione igiene e medicina preventiva” at the University of Padua (13 April 2018, Padua).

Rethinking Full Compensation: Cognitive Sciences Insights on Personal Injury Damages, presentation given at Annual Conference of Irish Association of Law Teachers (25 November 2017, Dunboynee).

How Medical Device Product Liability is Poised to Develop with The Rise of Digital Health and AI, presentation given at webinar "Medical Device Regulation and Digital Health" at Sant’Anna School of Advanced Studies (15 February 2021, Pisa).

3D Printing: Challenges to Product Liability Law, presentation given at Doctoral Workshop “Issues in Law and Technology” within the Internet festival (12 September 2017, Pisa).

Tecnologia e regolazione farmaceutica, presentation given at the “Tecnica e diritto pubblico” doctoral workshop (29 May 2017, Sant’Anna School of Advanced Studies).

Defective Pharmaceutical Product Liability, lesson given within the course “Case law and legislation developments in personal injury law: training in critical analysis of case law” (8 May 2017, LIDER Lab, Pisa).

Orphan drugs and competition law, presentation given at STALS – Sant’Anna Legal Studies Doctoral workshop (19 April 2017, Sant’Anna School of Advances Studies).

The future of orphan drugs, presentation given at European University Institute – Sant’Anna School of Advanced Studies joint workshop (23 September 2016, Sant’Anna School of Advanced Studies).

Neurosciences and Personal Injury Damages, presentation given at multiplier event of Areyoufine? Erasmus+ research project “Personal injury damages compensation and biomechanics” (12 July 2016, Sant’Anna School of Advanced Studies).

Il costo delle prestazioni per la procreazione medicalmente assistita, introductory remarks to a seminar within the course “A confronto diretto con la giurisprudenza” (18 May 2016, Sant’Anna School of Advanced Studies).

Member of organising commitee

FullCompensation - Rationalising Full Compensation of Non-Pecuniary Damages to Reconcile Equal Treatment and Personalisation: National stakeholder focus groups, seminar given at the Institute of Transnational Legal Research (METRO), Faculty of Law, Maastricht University (Maastricht, 20 September 2023)

FullCompensation - Rationalising Full Compensation of Non-Pecuniary Damages to Reconcile Equal Treatment and Personalisation: Case-law analysis and interviews, seminar given at the Institute of Transnational Legal Research (METRO), Faculty of Law, Maastricht University (Maastricht, 8 May 2023)

Full Compensation - Rationalising Full Compensation of Non-Pecuniary Damages to Reconcile Equal Treatment and Personalisation: Study design and protocol, seminar given at the Institute of Transnational Legal Research (METRO), Faculty of Law, Maastricht University (Maastricht, 5 October 2022)

FullCompensation - Rationalising Full Compensation of Non-Pecuniary Damages to Reconcile Equal Treatment and Personalisation: A Preparatory workshop, seminar given at the Institute of Transnational Legal Research (METRO), Faculty of Law, Maastricht University (Maastricht 31 May 2022)

The new Medical Device Regulation: Compliance Pills, presentation given at webinar “The EU Reg. 2017/745 on Medical Devices (MDR): Challenges and Opportunities” at Sant’Anna School of Advanced Studies (10 November 2020, Pisa).

IP / antitrust / product liability selected communications, given at international workshop “Cultures of taking pills: cultural attitudes and legal-ethical implications of assuming medicines” (9 November 2017, Sant’Anna School of Advances Studies).

The role of product liability on the intersections between food and drugs, presentation given at the international workshop “Eating and assuming: technical, legal and ethical borderlines between food and drugs” (19 September 2017, Sant’Anna School of Advances Studies).