The publication of ICH GCP E6(R3) Annex 2 marks an important step forward for clinical research. In Clinical Trials Arena, ICON's Wendy DeSpain, Global Head of Regulatory Strategy, explains that the most significant imp...

AI-enabled medical devices are entering a new phase. What began as tools for detection and triage is evolving into technology that can help inform diagnosis, treatment decisions and personalised care. As these capabili...

As regulators and HTA bodies place greater emphasis on real-world evidence, the European Health Data Space is creating new opportunities for cross-border research. Discover what EHDS means for study design, data access,...

The third article in MedTech Insight's PPWR series examines a growing challenge for medical device manufacturers: how to accommodate new packaging labelling requirements on already crowded device packaging. ICON’s Claud...

R&D in obesity therapeutics is outpacing regulation, leaving drug developers to navigate approval pathways still centred on weight-based endpoints. Emerging measures such as lean mass preservation and treatment durabilit...

Recently, colleagues from ICON’s Social Responsibility Chapter proudly joined Fundación Nacel Arcoíris to support the conservation of the Presa Madín ecosystem in Mexico. 110 volunteers came together to maintain 20 tree...

Latest issue now available. Join thousands of subscribers who have discovered the convenience of our free monthly publication, by signing up today. https://ow.ly/hTYQ50Zu7sT Compiled and collated by ICON’s Regulatory I...

The European Health Data Space (EHDS) is set to transform how real-world evidence is generated across Europe. In this article, ICON authors explore how CROs must adapt to a new landscape of secure data access, interoper...

As we recognise National Immunisation Awareness Month (#NIAM), it's important to remember that vaccine decisions for rare autoimmune conditions should be made on an individual basis. Discover key elements of a vaccine sc...

The second article in MedTech Insight's PPWR series explores one of the most misunderstood concepts in the EU's Packaging and Packaging Waste Regulation: the distinction between a packaging manufacturer and a producer. ...

From MS to NMOSD to early Alzheimer's disease, neurologic mAbs are delivering proven clinical benefit. But as efficacy becomes less of a differentiator, what determines whether these therapies reach patients? In this art...

Europe is emerging as an attractive route to global market access for Chinese sponsors. Early consideration of EMA requirements can help avoid costly delays and improve approval success. Read the article: https://ow.ly...