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.
Questions and answers on Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by marketing authorisation holders
Paracetamol should be taken as directed in the patient information leaflet
Timely detection and diagnosis of diseases are key elements of an efficient healthcare system. In recent years, artificial intelligence (AI) has played an increasingly important role in improving the accuracy and efficiency of disease diagnosis in clinical practice.
And much more...

Questions and answers on Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by marketing authorisation holders

EMA and WHO mark ten years of collaboration to advance global access to medicines

Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum I – Risk minimisation measures for medicinal products with embryo-fetal risks

Timely detection and diagnosis of diseases are key elements of an efficient healthcare system. In recent years, artificial intelligence (AI) has played an increasingly important role in improving the accuracy and efficiency of disease diagnosis in clinical practice.

OpenAI, the developer of ChatGPT, has made a couple of big hires as it prepares for a major expansion into healthcare.

Altuna Akalin and his team at the Max Delbrück Center have developed a new tool to more precisely guide cancer treatment. Described in a paper published in Nature Communications, the tool, called Flexynesis, uses deep neural networks and evaluates multi modal data.

Paracetamol should be taken as directed in the patient information leaflet

The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have jointly developed two new targets for clinical trials, to monitor progress against the ambition to…

In drug-safety monitoring systems, adverse events (AEs) associated with the use of medical products often consist of complex patterns of clinical events. Network analysis (NA) was used for pattern recognition and characterizing the Vaccine Adverse Event Reporting System (VAERS), but limited applications of NA to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) left its network description incomplete.
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