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For 20 years, ICON in Poland has been building expertise, supporting innovation and creating career opportunities. Today, we continue to grow. Whether you're looking for the variety and breadth of Full Service or the sp...

The difference between scientific investment and operational investment is a costly gap in neurologic mAb development, but it’s not inevitable. Safety frameworks, site capacity modeling and registry architecture aren't s...

There is no blanket exemption for medtech under the EU's new Packaging and Packaging Waste Regulation. In Medtech Insight, ICON's Claudia Anzaldo and Véronique Boscher (Perrin) explain why manufacturers should start pre...

Successful immunology development requires more than scientific innovation. It requires early and proactive regulatory strategy. As immunotherapies become more sophisticated, development programs must integrate CMC clin...

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...

AI-enabled software as a medical device is advancing rapidly, but regulatory expectations are becoming more demanding across every major market. Our latest whitepaper explores: - FDA Pre-Submission expectations for AI-...

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. ...

The rapid emergence of immunotherapies in autoimmune disease is creating new opportunities and new statistical challenges. At this year's ASA Biopharmaceutical Section Regulatory Industry Statistics Workshop, Patricia A...