Agostino Migone de Amicis > LCA Studio Legale > Milan, Italy > Lawyer Profile

Agostino Migone de Amicis

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Work Department

Life Science / Corporate M&A

Position

Of Counsel and Head of the Life Science Department

Career

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.

He 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.

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).

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.

Languages

Italian, English, French, German and Spanish

Memberships

He 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. 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, of the Life Sciences Working Group of Assolombarda and of the working group appointed by Regione Lombardia for the reform of clinical trials regulations.

Education

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