The new MHRA’s framework for clinical studies
By Giuliana Miglierini The repositioning of the United Kingdom as a global leader for clinical development of medicinal…
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…
Real-world evidence for regulatory decision-making
by Giuliana Miglierini Digitalisation is rapidly advancing also in the regulatory field, as a tool to improve the…
A new joint work plan to 2023 for EMA and EUnetHTA 21
by Giuliana Miglierini The new Regulation (EU) 2021/228 on Health Technology Assessment (HTA) will assume full validity in…