AI-Powered Pharmacovigilance: The Future of Drug Safety Surveillance
Artificial Intelligence (AI) refers to the simulation of human intelligence in machines, enabling them to perform tasks such as learning, reasoning, and problem-solving. In healthcare, AI has already shown significant promise in areas like diagnosis, treatment planning, and personalized medicine, transforming patient care delivery.
Overview of FDA Covered Product Authorization (CPA) and the CREATES Act
What is FDA Covered Product Authorization (CPA)?
FDA Covered Product Authorization refers to the official approval given by the U.S. Food and Drug Administration (FDA) for certain medical products to be marketed in the United States.
Health Canada Validation Criteria 5.3 – Compliance Update Effective May 31, 2025
As part of our continued commitment to regulatory compliance and operational excellence, we are notifying our clients, partners, and stakeholders about important updates to Health Canada’s Validation Criteria, version 5.3, which will come into effect on May 31, 2025.
Swissmedic Nitrosamine Risk Assessment Requirements
Swiss agency updated the guidance on nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents.
Scheduled Maintenance Notice: ESG NextGen Platform Downtime on May 17, 2025
