The first revision of the ERA guideline on environmental risk assessment
by Giuliana Miglierini It took eight years before revision 1 of the EMA guideline on environmental risk assessment…
Accelerating Clinical Trials in the European Union (ACT-EU)
The Multistakeholder Platform (MSP) and the position of the European Industrial Pharmacists Group (EIPG) by Rebecca Rebecca Stanbrook…
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…
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…
EMA’s 3-year work plan for the Quality domain
by Giuliana Miglierini The European Medicines Agency has released the input notes made by the GMDP Inspectors Working…
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…