As the European Union moves forward with revising Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), the European Parliament’s Committee on Environment, Public Health and Food Safety (SANT) is taking a central role in recalibrating the MedTech regulatory landscape.
The European Medicines Agency (EMA) has initiated a voluntary pilot testing a revised model for Pre-Submission Interactions (PSI) ahead of initial Marketing Authorisation Applications (MAAs).
This new Avicenna Alliance position paper, co-authored by Marc Horner, Ani Amar, Alejandro F. Frangi, Martha De Cunha Maluf-Burgman, Thierry Marchal and VPH Board of Director member, Francesco Pappalardo, describes a practical, risk-based framework to strengthen regulatory confidence and accelerate the adoption of in silico evidence.
The European Medicines Agency (EMA) has released a draft qualification opinion supporting the use of Virtual Control Groups (VCGs) as a replacement for Concurrent Control Groups (CCGs) in rat non-GLP dose-range finding (DRF) studies.
Technological innovation is only the first step. Turning it into better healthcare requires trust, governance, and the right policy environment.
We are pleased to highlight the publication of the new open access Springer book edited by Marc Horner, Jeff Bischoff, and Payman Afshari that provides the fundamental scientific principles of VVUQ related to computational modeling and simulation of medical devices.
The European Commission ’s new report, 'Observatory for Digital Health Technologies in Europe' emphasises the transformative impact of digital health technologies across the EU.
A recent event at the European Parliament brought renewed attention to the growing role of NAMs highlighting the forthcoming European Biotech Act as a major opportunity to accelerate the transition toward non-animal science while strengthening Europe’s global competitiveness.
The European Medicines Agency (EMA) has introduced a dedicated pilot procedure for scientific advice and protocol assistance on model-informed drug development (MIDD) — a significant step forward for the in silico community and a clear regulatory signal that quantitative modelling evidence is coming of age.
Our scientific officer, Janaki Raman, joined the global regulatory affairs community in Lisbon for RAPS Euro Convergence 2026 — and in silico medicine was firmly on the agenda.
The U.S. Food and Drug Administration (FDA) has released updated guidance aimed at strengthening how patient perspectives are incorporated into medical device decision-making throughout the total product life cycle.
Three important European consultations are currently open for feedback. These initiatives represent key opportunities to help shape policy and regulatory frameworks impacting research, innovation, and healthcare across Europe.
