Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more
On 9 October 2024, the European Data Protection Board (EDPB) published its Opinion 22/2024, clarifying the responsibilities of controllers when relying on processors and sub-processors. This guidance emphasizes the importance...more
In December 2023, political agreement was reached by EU policy makers on all substantive aspects of the EU Artificial Intelligence Act. Since then, the close-to-final text of this transformational piece of European...more
On 8 December 2023, after marathon “trilogue” negotiations, the Council of the EU, the European Parliament and European Commission reached a groundbreaking agreement on the forthcoming AI Act. Although the final text is still...more
The General Data Protection Regulation 2016/679 (GDPR) provides means to enforce provisions related to personal data processing by you as a data controller or data processor. It introduces collective actions everywhere in...more