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European Clinical trials with DRUGS are now governed by the EU Clinical Trial Regulation (CTR) 536/2014

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.

5 feb

European Clinical evaluations with In Vitro Diagnostics are now governed by the In Vitro Diagnostic Regulation 2017/746 + update 2023/607

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.

5 feb

European Regulation on personal data protection (EU/016/679)

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.

5 feb

European Clinical Investigations with Medical Devices are now governed by the Medical Device Regulation (MDR) 2017/745 + update 2023/607

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.

6 nov 2025