How to approach drug substance supply in new product introduction (NPI) processes by Giuliana Miglierini A key issue to be faced during pharmaceutical development refers to the supply of the…
ACT EU’s Workplan 2022-2026 by Giuliana Miglierini The implementation phase of the Accelerating Clinical Trials in the EU (ACT EU) initiative, launched…
EMA’s Industry stakeholders group (ISG) by Giuliana Miglierini The Industrial Stakeholder Group (ISG) is a new initiative recently launched by the European Medicines…
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…
Key issues in technical due diligences by Giuliana Miglierini Financial due diligence is a central theme when discussing mergers and acquisitions (M&A). Not less…
Trends in the development of new dosage forms by Giuliana Miglierini Oral solid dosage (OSD) forms (i.e. capsules and tablets) historically represent the most easy and…