EMA’s reflection paper on AI in the pharmaceutical lifecycle
by Giuliana Miglierini The rapidly evolving role of artificial intelligence (AI) and its possible application in the pharmaceutical…
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…
IVD regulation in force: new MDCG guidelines and criticalities for innovation in diagnostics
by Giuliana Miglierini The new regulation on in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746) entered into…
Artificial intelligence in medicine regulation
The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges…