This content is provided by Agostino Migone De Amicis.
Practice Areas
Agostino heads the Healthcare and Pharmaceutical department and is one of the foremost Italian regulatory/compliance advisers in the life sciences sector. With more than four decades’ experience in the field, he has unrivalled knowledge of the Italian regulatory landscape and longstanding relationships with all the major Italian regulatory bodies. He has advised on important regulatory matters last year, particularly in connection with important innovations of Italian legislation on clinical trials and related compliance aspects (informed consent, conflicts of interest, profit/non-profit studies and possible use of the latter data for registrative purposes); in 2019 he had an important authorship in a White Paper on Clinical Research, supported by FADOI and Fondazione Roche, and led a multi-disciplinary experts’ panel in drafting a public position paper on conflicts of interest. Beside acting as expert in criminal cases for corrupt practices, conducted around Italy an in-depth internal Laboratory on “Difficult Conversations” for a major pharma group with the medical field force.
Professional Memberships
Member, Ethics Committees of Humanitas (Chairman) and Istituto Nazionale dei Tumori, Milan. Regional Working Group on Clinical Trials, Assolombarda Life Sciences Desk, Federmanager Health Commission.
Personal
Milan University. Admitted 1977,Italy (1996 Supreme Court). Foreign Legal Consultant, New York (1997). Languages: Italian, English, French, German
