AI, Pharma Digital Transformation
The European Union and the United States published the Guiding Principles for Good AI Practices in Drug Development on January 14, 2026, as part of a strategic effort to harmonize regulatory criteria. The EMA-FDA collaborative work initiative has the mission of...
Pharma Digital Transformation, Pharma Digitalization
The FDA positions credibility as an indispensable condition for utilising AI in pharmaceutical regulatory decision-making, within a risk-proportionate framework that demands traceability, transparency and validation throughout the entire model lifecycle. This approach...
