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From clinical insights to candlelit conversations! Last week, our CEO, Evelyne Vermeersch, joined the Healixia Clinical Conference, followed by the BioWin Annual Dinner — a day where sharp minds met forward-thinking moves – and the future felt a little closer! 🧭 Major topic of the day? Belgium is stepping up. Starting January 1, 2026, initial applications for mononational Phase I–II trials will be assessed within 20 days, and Phase II/III–IV trials within 35 days (provided n

🚀 Big news from Belgium: clinical trial approvals go into fast-forward! Starting1 January 2026, the Belgian Federal Agency for Medicines and Health Products (FAMHP) will cut clinical trial approval timelines in half — positioning Belgium among the fastest regulators! These accelerated timelines will allow clinical research to start sooner, bringing innovative treatments faster to patients, without compromising on quality or safety. 💡 Why does this matter? With these new tim

Stay compliant with the EU Medical Device Regulation (MDR 2017/745) and its 2023/607 update. Discover key changes, extended transition timelines, and how the shift to a full product life-cycle approach impacts clinical investigations, safety reporting, and market access for medical devices.

European clinical trials involving medicinal products are governed by the EU Clinical Trial Regulation (CTR) No. 536/2014. Learn how this regulation streamlines approvals, enhances transparency, and access key tools like CTIS to manage and submit clinical trial applications efficiently.

Understand the EU In Vitro Diagnostic Regulation (IVDR 2017/746) and its 2023 update. Learn how stricter classification rules, enhanced clinical evidence requirements, and reinforced post-market surveillance impact IVD compliance, performance evaluation, and market access in Europe.

Learn how the EU General Data Protection Regulation (GDPR 2016/679) impacts clinical research and data handling. Discover key compliance requirements, patient data protection obligations, and best practices for managing personal data in clinical trials within the EU.