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    Information

    OFFICE
    Milan Office

    Via della Moscova 18, 20121
    Tel: +39 02778875313
    Fax: +39 0276018478
    EMAIL: agostino.migone@lcalex.it

    LANGUAGES
    Italian English French German Spanish
    PROFESSIONAL ORDER

    Italy (Milan Bar)

    Admitted before the Supreme Courts

    Foreign Legal Consultant in the State of New York since 1997

    PERSONAL ASSISTANT

    Rosanna Luporini
    rosanna.luporini@lcalex.it

    Of Counsel

    Agostino
    Migone de Amicis

    quote icon
    The quantities compete for space, the qualities complement each other. Dietrich Bonhöffer
    quote icon
    The quantities compete for space, the qualities complement each other. Dietrich Bonhöffer

    Information

    OFFICE
    Milan Office

    Via della Moscova 18, 20121
    Tel: +39 02778875313
    Fax: +39 0276018478
    EMAIL: agostino.migone@lcalex.it

    LANGUAGES
    Italian English French German Spanish
    PROFESSIONAL ORDER

    Italy (Milan Bar)

    Admitted before the Supreme Courts

    Foreign Legal Consultant in the State of New York since 1997

    PERSONAL ASSISTANT

    Rosanna Luporini
    rosanna.luporini@lcalex.it

    Agostino predominantly deals with regulatory matters in the areas of pharmaceuticals, medical devices and nutraceutics and extends these important areas connected to clinical research.

    Throughout his long and valuable experience, gathered through continuing assistance to manufacturing companies and acting as a consultant or member of institutions (e.g., Independent Ethics Committees, research centers, public and private foundations), he specifically handled matters concerning development of new products from their design to industrialization, clinical trials for registration, marketing authorization, obtaining prices and reimbursement, participation in public procedures for the awarding of supplies to the National Health Service, distribution and promotion/scientific information, continuing training of healthcare professionals (CCE), pharmacovigilance, clinical trials and observational studies aimed at obtaining additional indications (for profit as well as non-profit purposes). He had also handled all compliance issues of the Life Sciences sector (such as personal data protection, prevention of corrupt practices, behavioral models and vigilance according to Decree 231/2001), as well as extraordinary and joint venture transactions, and the related civil, criminal and administrative judicial procedures.

    Beside specialist activities, he has always assisted clients in various fields of civil, commercial, corporate and EU law, particularly in environmental, public and private tenders, agri-food and biotechnologies, and generally with respect to activities governed by special regulations.

    In 2011, he was awarded the TopLegal “Professional of the Year – Life Science” prize and has been constantly ranked in the last years in international directories such as Chambers, the Legal 500 and Who’s Who Legal.

    Professional experience

    From 1975 to 2020 Agostino was a member of the Law Firm Pavia e Ansaldo, being a partner from 1986 to 2016, and of counsel from 2017 to 2020, and heading the Life Sciences – Regulatory Department. His joining LCA since 2021, together with younger valuable professionals, further strengthens and consolidates the experience and goodwill of the Firm, which is already significant in this important sector, and offers to clients an increasingly qualified and efficient service in the many articulations of the healthcare/pharmaceutical world.

    In the past, he was an assistant professor of the 1st Chair of International Law at the Law Faculty of the University of Milan. From 2008 to 2014, he held seminars of French legal language at the University of Milan and of Administrative Law at the Catholic University of Milan.

    Associations, seminars, media and other activities

    Agostino has been a member of the Independent Ethics Committee of Istituto Clinico Humanitas, and Chairman thereof since 2014, as well as of the National Cancer Institute of Milan. As of June 2021 he has been appointed by the Ministry of Health as a member of the National Coordination Center of the local Ethics Committees for clinical trials of drugs and medical devices. From 2016 to 2018, he was a Director of the research Foundation “Istituto Neurologico Nazionale Carlo Besta” in Milan, by appointment of the Mayor of Milan. He is a member of the Healthcare Committee of Federmanager, of the Life Sciences Desk of Assolombarda and of the Life Sciences Working Group of Assolombarda.

    Lecturer in seminars on clinical trials, privacy and clinical research, biobanking, compliance in the pharma sector and pharmacovigilance, in 2014 he was a speaker at the European Pharmaceutical Law Forum on “Paediatric Clinical Trials in a changing EU regulatory framework”. Agostino has been a consultant to the Scientific Directorate of Fondazione FADOI (Federation of Internal Medicine Hospital Managers), as reviewer of the 2016 Report “Clinical Research by Non-Profit Sponsors”, speaker to the 5th National Congress at the Ministry of Health and co-author of the 2018 Report. He is the author of the position paper “Conflicts of Interest and the Future of Clinical Research in Italy (independent or not)” and co-author of the White Paper on independent clinical research in Italy, supported by Fondazione Roche and Fondazione FADOI, published by EDRA (2019).

    Education

    Law degree, magna cum laude, University of Milan (1974)

    Acknowledgments

    Leading Individual for Healthcare and Life Sciences

    Ranked Lawyer for Life Sciences

    quote icon
    "We have always appreciated his ability to approach the client and understand their needs." Chambers Europe 2024
    "Agostino Migone has incredible experience." The Legal 500 EMEA 2024

    Information

    OFFICE

    Milan Office

    Via della Moscova 18, 20121
    Tel: +39 02778875313
    Fax: +39 0276018478
    EMAIL: agostino.migone@lcalex.it

    LANGUAGES
    Italian English French German Spanish
    PROFESSIONAL ORDER

    Italy (Milan Bar)

    Admitted before the Supreme Courts

    Foreign Legal Consultant in the State of New York since 1997

    PERSONAL ASSISTANT

    Rosanna Luporini
    rosanna.luporini@lcalex.it

    Areas of activity

    Agostino predominantly deals with regulatory matters in the areas of pharmaceuticals, medical devices and nutraceutics and extends these important areas connected to clinical research.

    Throughout his long and valuable experience, gathered through continuing assistance to manufacturing companies and acting as a consultant or member of institutions (e.g., Independent Ethics Committees, research centers, public and private foundations), he specifically handled matters concerning development of new products from their design to industrialization, clinical trials for registration, marketing authorization, obtaining prices and reimbursement, participation in public procedures for the awarding of supplies to the National Health Service, distribution and promotion/scientific information, continuing training of healthcare professionals (CCE), pharmacovigilance, clinical trials and observational studies aimed at obtaining additional indications (for profit as well as non-profit purposes). He had also handled all compliance issues of the Life Sciences sector (such as personal data protection, prevention of corrupt practices, behavioral models and vigilance according to Decree 231/2001), as well as extraordinary and joint venture transactions, and the related civil, criminal and administrative judicial procedures.

    Beside specialist activities, he has always assisted clients in various fields of civil, commercial, corporate and EU law, particularly in environmental, public and private tenders, agri-food and biotechnologies, and generally with respect to activities governed by special regulations.

    In 2011, he was awarded the TopLegal “Professional of the Year – Life Science” prize and has been constantly ranked in the last years in international directories such as Chambers, the Legal 500 and Who’s Who Legal.

    Professional experience

    From 1975 to 2020 Agostino was a member of the Law Firm Pavia e Ansaldo, being a partner from 1986 to 2016, and of counsel from 2017 to 2020, and heading the Life Sciences – Regulatory Department. His joining LCA since 2021, together with younger valuable professionals, further strengthens and consolidates the experience and goodwill of the Firm, which is already significant in this important sector, and offers to clients an increasingly qualified and efficient service in the many articulations of the healthcare/pharmaceutical world.

    In the past, he was an assistant professor of the 1st Chair of International Law at the Law Faculty of the University of Milan. From 2008 to 2014, he held seminars of French legal language at the University of Milan and of Administrative Law at the Catholic University of Milan.

    Associations, seminars, media and other activities

    Agostino has been a member of the Independent Ethics Committee of Istituto Clinico Humanitas, and Chairman thereof since 2014, as well as of the National Cancer Institute of Milan. As of June 2021 he has been appointed by the Ministry of Health as a member of the National Coordination Center of the local Ethics Committees for clinical trials of drugs and medical devices. From 2016 to 2018, he was a Director of the research Foundation “Istituto Neurologico Nazionale Carlo Besta” in Milan, by appointment of the Mayor of Milan. He is a member of the Healthcare Committee of Federmanager, of the Life Sciences Desk of Assolombarda and of the Life Sciences Working Group of Assolombarda.

    Lecturer in seminars on clinical trials, privacy and clinical research, biobanking, compliance in the pharma sector and pharmacovigilance, in 2014 he was a speaker at the European Pharmaceutical Law Forum on “Paediatric Clinical Trials in a changing EU regulatory framework”. Agostino has been a consultant to the Scientific Directorate of Fondazione FADOI (Federation of Internal Medicine Hospital Managers), as reviewer of the 2016 Report “Clinical Research by Non-Profit Sponsors”, speaker to the 5th National Congress at the Ministry of Health and co-author of the 2018 Report. He is the author of the position paper “Conflicts of Interest and the Future of Clinical Research in Italy (independent or not)” and co-author of the White Paper on independent clinical research in Italy, supported by Fondazione Roche and Fondazione FADOI, published by EDRA (2019).

    Education

    Law degree, magna cum laude, University of Milan (1974)

    Acknowledgments

    Acknowledgments

    Leading Individual for Healthcare and Life Sciences

    Ranked Lawyer for Life Sciences

    quote icon
    "We have always appreciated his ability to approach the client and understand their needs." Chambers Europe 2024
    "Agostino Migone has incredible experience." The Legal 500 EMEA 2024
    Commercial and corporate
    Litigation, Arbitration and ADR

    Commercial and corporate

    While LCA can offer and support you in a broad variety of services, we pride ourselves on consultancy for company law, domestic and international corporate contracts, commercial and corporate litigation and all the regulatory aspects typical of the various markets involved.
    LINK

    Litigation, Arbitration and ADR

    At LCA, our expert advisors will assist you in the prevention, management and resolution of disputes, in civil and commercial matters. Whether you’re based in Italy or abroad, before an ordinary or special court, or subject to national and international arbitrations, we’re by your side every step of the way.
    LINK
    Life Sciences
    Manufacturing

    Life Sciences

    Also in the Life Sciences industry, our dedicated team combines cross-departmental skills and expertise to support a wider range of clients. We work with entrepreneurs, institutions, investors and domestic and international funds operating in the Life Science and Healthcare fields, providing full multi-disciplinary assistance, based on the experience and the real and in-depth knowledge of the specific issues of this industry.
    LINK

    Manufacturing

    The complex world of manufacturing can feel overwhelming. Comprising small and medium-sized companies, as well as renowned multinationals, it encompasses and straddles a multitude of sectors and markets, each with its own specific characteristics and specific corporate, commercial, contractual, organisational and operational features. Here at LCA, we can help your company meet its full business potential, in compliance with the numerous and changing regulations in force. With profound and expert knowledge of the industry, we can provide accurate, rapid and targeted solutions to meet your needs.
    LINK

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