Getting overwhelmed by the news is an everyday struggle for those wishing to stay in touch with the latest news. Our newsletter should make it easier for those interested in pharmacovigilance regulations, advancement in the relevant use of artificial intelligence, and personal growth. Approaching with care, the same as we provide PV services, we thoughtfully pick articles every month to keep you updated.
Electronic product information (ePI) refers to the authorised, statutory product information for medicines (including the summary of product characteristics, package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and in print.
The World Health Organization (WHO) today designated the Digital Ethics Centre at Delft University of Technology in the Netherlands as a WHO Collaborating Centre on artificial intelligence (AI) for health governance.
The Pharmacovigilance Risk Assessment Committee (PRAC) plays a central role in the European Union’s pharmacovigilance system, evaluating drug safety through several procedures and activities. Despite its central role, few studies have quantitatively investigated the PRAC’s activities from a system’s perspective.
And much more...
MedDRA important medical event terms list - version 28.0
Electronic product information (ePI) refers to the authorised, statutory product information for medicines (including the summary of product characteristics, package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and in print.
2024-2026 Work Plan of the Good Clinical Practice Inspectors Working Group (GCP IWG)
The World Health Organization (WHO) today designated the Digital Ethics Centre at Delft University of Technology in the Netherlands as a WHO Collaborating Centre on artificial intelligence (AI) for health governance.
To deal with the mountains of hardware being used and discarded in the AI boom, companies need to embrace the circular economy.
Manual identification of case narratives with specific relevant information can be challenging when working with large numbers of adverse event reports (case series). The process can be supported with a search engine, but building search queries often remains a manual task. Suggesting terms to add to the search query could support assessors in the identification of case narratives within a case series.
The Pharmacovigilance Risk Assessment Committee (PRAC) plays a central role in the European Union’s pharmacovigilance system, evaluating drug safety through several procedures and activities. Despite its central role, few studies have quantitatively investigated the PRAC’s activities from a system’s perspective.
If you follow Evaluate’s regular white papers and blogs, you may be familiar with our annual report that investigates the state of the orphan drug market. I’ve been involved in analyzing that data for the past three years, and have just finished the process for this year’s report which will be published soon.
Patient advocates and safety experts have called for meaningful patient engagement since the beginning of the patient safety movement, yet significant gaps remain. Patient engagement is defined as “patients, families, their representatives, and health professionals working in active partnership at various levels across the health care system—direct care, organizational design and governance, and policymaking—to improve health and health care.”
9-11 April 20225 - 14_00 - 18:30
05-07 May 2025 - 14:00 - 18:00
12-16 May 2025 - 14:00 - 18:30
These are the trainings that NextPV representatives will execute in this and the upcoming month.
Pictures used in this newsletter were generated by AI.