Clinical Trials Regulation

EU Life Sciences Strategy, comments to the call for evidence

The call for evidence closed on 17 April, and the proposal of the draft EU Life Sciences Strategy is expected by Q2 2025. It should encompass all the different industrial sectors in which life sciences play a central role for R&D and competitiveness, including pharmaceuticals, biotech and medtech

ACT EU’s Workplan 2022-2026

by Giuliana Miglierini The implementation phase of the Accelerating Clinical Trials in the EU (ACT EU) initiative, launched…

Approval of the Data Governance Act, and EMA’s consultation on the protection of personal data in the CTIS

by Giuliana Miglierini The Data Governance Act (DGA) was approved and adopted in May 2022 by the European…

ACT EU: the EU’s vision for the future of clinical trials

by Giuliana Miglierini Just few days before the entry into force of the new Clinical Trials Regulation and…