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…
ICMRA, two pilot programmes to optimise regulatory assessment and inspections
by Giuliana Miglierini New flexible modalities for the management of regulatory procedures are becoming progressively accepted even for…
The transition towards EMA’s new Digital Application Dataset Integration (DADI) user interface
by Giuliana Miglierini The Digital Application Dataset Integration (DADI) network project is aimed to replace the current PDF-based…
EMA’s OMS has turned mandatory for centrally authorised products
by Giuliana Miglierini Since November 1st, 2021, the use of the Organisation Management Service (OMS) became mandatory for…