Medical Governance

Nicole Dale

The EU Biotech Act Puts Medical AI Safeguards at a Crossroads

Pharmatica image of a petri dish filled with blue liquid and ringed by twelve gold stars, with a single red drop sending ripples across the surface. It illustrates the EU Biotech Act and the debate over medical AI safeguards.

The EU Biotech Act aims to accelerate biotechnology development. Explore how proposed medical AI reforms could affect patient safety, compliance, and pharma competitiveness.

Nicole Dale

What Changes in EMA GVP Module III Revision 2?

Pharmatica image showing a magnifying lens inspecting a connected pharmacovigilance vendor network beside regulatory documents, with vivid red accents.

GVP Module III Revision 2 took effect on 10 September 2026. See what changes for subcontractor oversight, PSMF access, remote inspections, and risk planning.

Nicole Dale

AI Bioweapons Risk: What Anthropic’s Report Means for Pharma

Pharmatica image representing a pharmaceutical AI research environment that uses AI biosecurity, biological research governance, and emerging bioweapons risk.

The Anthropic 2026 threat report documents a significant bioweapons risk. See what this means for pharma biosecurity, research, and AI controls.

Nicole Dale

FDA 10 Guiding Principles of Good AI Practice in Drug Development

Pharmatica image to represent the FDA’s 10 Guiding Principles of Good AI Practice in Drug Development showing AI evidence analysis within a pharmaceutical regulatory setting.

Get to know the FDA 10 Guiding Principles of Good AI Practice in Drug Development and what they mean for AI governance, validation, and regulatory risk.

Nicole Dale

World’s First Live AI-Assisted Brain Surgery

Pharmatica photo‑realistic image of an operating theatre showing surgeons performing AI‑assisted brain surgery under bright ambient light, with monitors displaying glowing yellow neural pathways and blue data overlays, representing real‑time computer vision guidance and surgical precision.

In the world’s first, London surgeons have used real-time AI to protect a patient's sight during live brain surgery. See what the trial’s AI framework means for MedTech.

Nicole Dale

What Sponsors Need to Know About UK Combined Review 2026

Pharmatica image for UK Combined Review clinical trial approval showing coordinated MHRA and ethics assessment through a unified CTIMP regulatory pathway.

UK Combined Review unifies MHRA and ethics review for CTIMPs, reshaping approval timelines, submissions, and sponsor planning under UK trial reform.

Nicole Dale

Genomic Governance Ensures Equity at the Core of Drug Discovery

Scientists analysing diverse genomic datasets to support genomic equity, AI-driven drug discovery, and precision medicine in pharmaceutical research.

Discover why genomic equity is essential for reliable AI-driven drug discovery, precision medicine, and building more representative pharmaceutical innovation.