EU news

EVENT | 20th Biosimilar Medicines Conference by MFE

During these two interactive days, actors of the healthcare community alongside world experts in biosimilar medicines will gather and debate the evolving biosimilar medicines landscape and emerging trends. Discussion will focus on sharing good practices and setting collective aims to achieve the depth, breadth and speed of the use of biosimilar medicines as a lever to untap their transformative value.

The European Union’s AI Act & its Impact on Medical Devices

The AI Act (AIA) is the EU’s first attempt to create a comprehensive AI regulatory framework and aims to ensure the protection of fundamental rights in this field. AI applications used in healthcare are often ‘medical devices’ and are thus regulated under the EU Medical Devices Regulation (MDR).

EVENT | PMS Info-day

Specially aimed at representatives from human trade organizations and national competent authorities

NEWS | ICH Q14 Guideline on analytical procedure development

This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the evaluation of the quality of drug substances and drug products. It complements ICH Q2 Validation of Analytical Procedures.

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