> 5' HEALTHCARE SUMMIT / RELATORI / Agostino Migone de Amicis

Agostino Migone de Amicis

Partner e Responsabile Dipartimento Sanità e Farmaceutico (regolatorio) Studio legale Pavia e Ansaldo

26/10/2016  
 
Born Rosignano Solvay (Livorno), 18 May 1951. J.D. cum laude, Università degli Studi di Milano (1974). Admitted to the Milan Bar (1977) and Italian Supreme Court (1996). Foreign Legal Consultant in the State of New York (1997).
Joined Pavia e Ansaldo in 1975, partner since 1986; in charge of the HealthCare and Pharmaceuticals Law Department.
Chairman of the Independent Ethics Committee of Istituto Clinico Humanitas, Rozzano (MI). Board Member, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan (as representative of the Municipality of Milan). Reviewer of the 2016 edition of the FADOI Report on independent clinical research. “Professional of the Year- Life Sciences” (2011, Top Legal Magazine).
Main areas of activity: pharmaceutical and clinical research law; biotechnologies; compliance and matters governed by special legislation, with particular regard to the relevant contractual, corporate, procedural issues and related litigation (civil and administrative, arbitration). Experienced in the field of prevention and compliance (Italian Decree 231/2001); administrative and environmental law.
Assistance and advice in regulatory/compliance matters, particularly related to clinical trials and advanced therapies, are rendered to pharmaceutical Companies as well as national and international groups of investigators and research Centers, with regard to the legal aspects of studies and trials (contracts, approval procedures, informed consent and personal data protection) at national, EU and international levels. Speaker at congresses on clinical trials and research, biobanking, privacy and compliance (“Paediatric clinical trials in a changing EU Regulatory framework” - European Pharmaceutical Law Forum, Brussels 2014).

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