This guideline defines an harmonised framework for evaluating MIDD evidence and provides recommendations for related planning and regulatory interactions, implementation, reporting, and submission. In the rapidly evolving landscape of drug development, model-informed drug development (MIDD)...
EMA and the U.S. Food and Drug Administration (FDA) have jointly identified ten principles for good artificial intelligence (AI) practice in the medicines lifecycle. The principles give broad guidance on AI use in evidence generation...
The VHT-AI Thematic Network invited stakeholders to an interactive webinar exploring how Artificial Intelligence serves as the facilitator for realizing the vision of Virtual Human Twins in Europe. Read the minutes published by DG Health and...
The European Medicines Agency (EMA) is hosting a workshop on supporting innovation in cardiovascular medicines and medical devices in the EU. This multi-stakeholder workshop will cover interdisciplinary discussions addressing a range of important topics including...
European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) are hosting a workshop on AI. The workshop has the following objectives: To provide keynotes on AI state-of-the-art To update stakeholders on: the evolving regulatory...
New projects funded under the 2024 EU4Health calls for proposal aimed at advancing digital healthcare across the EU have recently started. Read the news article published by European Health and Digital Executive Agency on 3 December...
The 20 and 21 November 2025, European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) are hosting a workshop on AI. The workshop has the following objectives: To provide keynotes on AI state-of-the-art To update stakeholders...
This report presents considerations for future action and proposes a monitoring and indicators framework that could enable progress to be tracked with the view of enabling the sustainable integration of AI into healthcare systems. Read...
The Commission invites health stakeholders to submit proposals for a new cycle of Thematic Networks under the EU Health Policy Platform. The deadline for submissions is 22 August 2025. The Thematic Networks are intended to...
European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) are hosting a workshop on AI. The workshop has the following objectives: To provide keynotes on AI state-of-the-art To update stakeholders on: the evolving regulatory environment HMA/EMA...
