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"Plan early" remains key in the new EU HTA landscape. Companies should proactively map evidence needs across key countries, pursue joint scientific advice where possible, and allocate additional time and budget for anal...

Because combination products do not fit neatly into a single category, their regulation can be difficult to navigate. However, there are several broad strategies that can help guide planning for drug-device combination p...

For APAC biotechs with global ambitions, choosing the right regulatory pathway can be a critical strategic decision. In PharmaTimes Magazine, ICON’s Senior Director of Regulatory Strategy, Graham Bell, explores the comp...

Agentic AI is reshaping how work is executed in biopharma. In this Bio-IT World article, ICON’s SPV of Enterprise AI, Tony Clarke, explores the shift from task-based automation to coordinated, autonomous workflows – whe...

Sites are often asked to adapt to sponsor and CRO processes that sit outside their day-to-day workflows. What if we took a different approach? Join Brian Mallon (ICON), Scott Uebele (Advarra), Denise Snyder (Duke Univer...

The first EU Joint Clinical Assessments (JCAs) may reduce some duplication in clinical assessments, but they are also creating new challenges for evidence planning. Mia Malmenäs of ICON notes that manufacturers are navi...

Companies that have not historically developed biosimilars are recognising the opportunity represented by recent regulatory changes. Discover how the biosimilars market is being impacted and how developers can help the...

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/Hxx750Zi8bm. Compiled and collated by ICON’s Regulatory ...

Join us tomorrow at the SCDM India Single Day Event in Hyderabad, where ICON's Gangotri Boni will serve as Event Co Chair and lead the session, 'Transforming information into insights'. Discover how data can be transfo...

To mark International Yoga Day, colleagues across India took part in Desktop Yoga Week, a wellbeing initiative designed to encourage simple moments of movement and mindfulness during the working day. More than 850 colle...

Last week, we officially relocated our Guangzhou office, marking an exciting milestone for our growing team in China. The new workspace offers upgraded facilities, a modern working environment, improved accessibility, a...

Join us at this year's SCDM India Single Day Event on 11 July in Hyderabad, where ICON's Gangotri Boni will be serving as Event Co Chair and chairing the session, 'Transforming information into insights'. Discover how ...