Mario Draghi’s report, a focus on the proposed actions for the pharma sector
by Giuliana Miglierini The report on the Future of European competitiveness was presented by Mario Draghi on 17…
EMA’s pilot scheme for academic and non-profit development of ATMPs
by Giuliana Miglierini Advanced therapy medicinal products (ATMPs) are often developed by academic and non-profit organisations, because of…
Swissmedic’s technical interpretation of Annex 1
by Giuliana Miglierini New insights on the interpretation of the new Annex 1 to Good manufacturing practices (GMPs)…
The risk of a biosimilar void in Europe
by Giuliana Miglierini The undergoing revision of the pharmaceutical legislation aims, among others, to redefine data protection to…
Review of the pharmaceutical legislation, the proposals of the industrial associations
By Giuliana Miglierini The Staff Working Document on “Vulnerabilities of the global supply chains of medicines” published by…
EMA’s new Quality Innovation Expert Group (QIG)
by Giuliana Miglierini Innovative approaches to the development manufacturing and quality control of medicines are becoming the new…