Reform of pharma legislation: the debate on regulatory data protection by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision…
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…
ICMRA report on best practices against antimicrobial resistance by Giuliana Miglierini Antimicrobial resistance (AMR) is the consequence of mutations that allow microbes to survive pharmacological treatment.…
ACT EU’s Workplan 2022-2026 by Giuliana Miglierini The implementation phase of the Accelerating Clinical Trials in the EU (ACT EU) initiative, launched…
Revision of the PIC/S GMP Guide: Annex 13 and Annex 16 by Giuliana Miglierini The entry into force of EU Regulation 536/2014 “Clinical trials”, at the end of January,…