PAVIA E ANSALDO SPONSOR OF THE 5TH HEALTHCARE SUMMIT OF IL SOLE 24 ORE
Agostino Migone De Amicis, partner of Pavia e Ansaldo, participated as speaker on “Research and independent experimentation: hub or … handicap for the development of Italian excellence?”
Milan, October 26, 2016 - The 5th Healthcare Summit organized by Il Sole 24 Ore sponsored by, among others, Pavia e Ansaldo took place today in Rome.
Agostino Migone De Amicis, partner and head of the Health and Pharmaceutical (Regulatory) Department of Pavia e Ansaldo as well as Chairman of the Ethics Committee of Humanitas, participated as speaker in the first part of the meeting. In his presentation on “Research and independent experimentation: hub or … handicap for the development of Italian excellence?”, he analyzed the present situation and the recent developments of Italian regulation on clinical studies not promoted by pharmaceutical entities.
“The Italian system is the only one in Europe that defines clinical studies which are not undertaken by pharmaceutical companies as “no profit” and applies an outdated set of regulation. This often creates obstacles and burocratic delays for approvals and protocols realised by researchers. Moreover, the incorrect interpretation of regulation leads to further distortions which have a negative impact on the activities of Italian researchers and the relationships between institutions and pharmaceutical companies. We urgently need to create solutions apt to control this delicate matter in a dynamic manner which is coherent with international developments. These developments increasingly consider the importance of the assessment of the independence of the research, the use of its data as part of the registration procedure and the overall weight on the cost of research for the national social security carriers. New regulation should permit the raising of funds and their investment in further independent research in a transparent matter”, explained Mr. Migone.